Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) QS6-BXXCS, UDI/DI 00732094263176, Serial Numbers: 116350524925, 116490541255; b) QS-6CC-DGCXX, UDI/DI 00732094308716, Serial Numbers: 119050000134; c) QS-6CC-DFCXX, UDI/DI 00732094308723, Serial Numbers: 122290000606, 122230001869, 122230001868, 122150001605, 122150001604, 122090000843, 119310001134, 119240000440, 122430000522, 122430000523, 119050000135; d) QS-6JB-AXAXA, UDI/DI 00732094263206, Serial Numbers: 123170000019; e) QS6-BLXCX, UDI/DI 0081234502761721, Serial Numbers: 116090330912, 116100344488, 116100344490, 116140389225, 116150394312, 116180422821, 116180422823, 116210442892, 116220445992, 116230451848, 116230455471, 116260496356, 116310521226, 116310521294, 116310521295, 116340523119, 116370526978, 116400530719, 116500543975, 116520546015, 117090555819, 117120557453, 117240573603, 117240573604, 117240573605, 117240573606, 117250575355, 117250575356, 117310581182, 117320582007, 117330583105, 117330583106, 117420591117, 117480596687, 117510602012, 117520603268, 118020605912, 118040608668, 118050610650, 118180633950, 118180633951, 118250001740, 118210638580, 118360000413, 118360000414, 118360000415, 118400000214, 119090001180, 119170000426, 119200000235, 119250000559, 119350003341, 119350003342, 119400001642, 119400001643, 119390002403, 119450000815, 119470000523, 119470000524, 120190001489, 120340001206, 120370000113, 120390000395, 120450000603, 117380587441, 121040002696, 121320000296, 121400000048, 121420000470; f) QS6-BLXC1, UDI/DI 0081234502760021, Serial Numbers: 116110351990, 116170411313, 116180422820, 116190425267, 116200431781, 116200435830, 116200435832, 116210440257, 116210442845, 116220445031, 116220447262, 116220447261, 116220448956, 116240457509, 116240461442, 116240461206, 116250486048, 116250485976, 116250489753, 116260496350, 116260496357, 116260496358, 116260496359, 116270498882, 116280504766, 116280504767, 116280505422, 116290511314, 116290511315, 116290516779, 116300519942, 116300520698, 116310521231, 116310521175, 116320522055, 116330522666, 116340523645, 116370526300, 116370526302, 116380527090, 116370526980, 116390528637, 116380528395, 116390529243, 116390529244, 116390529289, 116390529290, 116390529245, 116390529246, 116400530260, 116430534181, 116440534647, 116440535722, 116450535995, 116460537454, 116460537582, 116490541890, 116500544101, 116500544003, 116510545088, 116520546283, 116530547307, 116530547308, 116530547309, 116520546501, 116530547394, 117010549346, 117020550273, 117040551450, 117030550903, 117050552567, 117080554660, 117110556288, 117120556595, 117140562002, 117170565229, 117170566105, 117230572559, 117230572529, 117230572792, 117230572972, 117240573048, 117240573453, 117240573579, 117280577601, 117290579316, 117300580356, 117320581836, 117320581837, 117320582120, 117380587062, 117390588108, 117450593979, 117450593976, 117450593977, 117450593978, 117480597797, 117480597798, 117480597583, 117480597584, 117520603269, 117520603562, 118040607784, 118090615610, 118090615611, 118140626430, 118150627079, 118160628175, 118150627075, 118150627074, 118150627073, 118150627072, 118150627071, 118150627070, 118150627069, 118120623174, 118180633959, QS6-BLXC1, 118180634187, 118310001237, 118340000912, 118340000913, 118340000914, 118370000773, 118380001940, 118460001584, 118480000810, 118490000217, 118520000406, 119040000078, 119110000757, 119150000254, 119160000043, 119190000970, 119250000554, 119280001984, 119290000535, 119500001105, 120020000304, 120100001917, 120220001572, 120220001573, 120230001261, 120320000243, 120320000244, 120300000912, 120360001047, 121070000465, 121070001280, 121100002344, 121100002345, 121130001104, 121180000761, 121340000883, 121370002510, 121390000795, 121460001255, 122200001819, 122480002102, 123300001831; g) QS-6AC-XXAXX, UDI/DI 00732094301076, Serial Numbers: 123240000013, 123240000012, 123240000011, 123240000010, 123240000009, 120400002601, 120400002600, 120400002599, 120400002598, 120400002597, 120210000914, 120210000913, 120210000912, 120210000911, 120210000910, 120210000909, 120210000908, 120210000907, 120210000906, 120210000905, 120210000904, 120210000903, 119330001329, 119330001328, 119330001327, 119330001326, 119330001325, 119330001324, 119330001323, 119320001019, 119320001018, 119320001017, 119320001016, 119320001015, 119180001173, 119180001172, 119180001171, 119180001170, 119110000755, 118430000951, 11840000949, 118430000948, 118430000949, 123310000826, 123310000827, 123310000828, 123310000829, 123310000830, 123430000320, 123430000321, 123430000322, 123430000323, 123430000324, 123430000325, 123430000326, 123430000327, 123430000328, 123430000329; h) QS-6AC-XXBXX, UDI/DI 00732094346633, Serial Numbers: 123040001807, 123040001806, 123040001805, 123040001804, 123040001803, 122510000875, 122510000874, 122510000873, 122510000872, 122510000871, 122480001730, 122480001729, 122480001728, 122480001727, 122480001726, 122250001966, 122250001965, 122250001964, 122250001963, 122250001962, 122240000488, 122240000487, 122240000486, 122240000485, 122240000484, 122160000349, 122160000348, 122160000347, 122160000346, 122160000345, 122010000998, 122010000997, 122010000996, 122010000995, 122010000994, 121490000353, 121490000352, 121490000351, 121490000350, 121490000349, 121320000685, 121320000684, 121320000683, 121320000682, 121320000681, 121090000175, 121090000174, 121090000173, 121090000172, 121090000171; i) QS-6AC-XXAXA, UDI/DI 00732094355314, Serial Numbers: 123400000592, 123400000593; j) QS6-AXTDS, UDI/DI 00812345027587, Serial Numbers: 116120372696; k) QS-6AC-AXAAA, UDI/DI 00732094263855, Serial Numbers: 118520000406; l) QS-6AC-CXBXA, UDI/DI 00732094263794, Serial Numbers: 116330522481; m) QS-6AC-DXAXA, UDI/DI 00732094263756, Serial Numbers: 116070309986; n) QS-6AC-XXBXA, UDI/DI 00732094263732, Serial Numbers: 117380586614; o) QS6-MXTCS, UDI/DI 0081234502767921, Serial Numbers: 116150390529, 116210438777, 116530547233, 116530547234, 116530547235; p) QS-6AC-CGAAB, UDI/DI 00732094326604, Serial Numbers: 119470001903; q) QS-6AC-XAAXA, UDI/DI 00732094263749, Serial Numbers: 117280578329; r) QS-6AC-DEAAX, UDI/DI 00732094263787, Serial Numbers: 117120558685; s) QS-6AC-DFAAX, UDI/DI 00732094263763, 117160563895; t) QS-6AC-EEBXX, UDI/DI None, Serial Numbers: 118200636641; u) QS-6AC-CFBAB, UDI/DI 00732094318029, Serial Numbers: 123130002242; v) QS-6AC-CFAAA, UDI/DI 00732094263824, Serial Numbers: 122060000614, 121270000363, 117210570696; w) QS-6AC-CFBAA, UDI/DI 00732094318111, Serial Numbers: 123130000023, 123130000022, 123130000021, 123130000020, 123130000019, 123130000018, 122380000698, 121450000731, 121450000730, 123290000564, 123290000565; x) QS-6AC-DFAAA, UDI/DI 00732094263770, Serial Numbers: 118440001972, 119260000952, 119080001406, 119080001405, 118500002162, 118440001973, 118210638583, 118200636642, 118050610062, 118040608669, 117490599962, 117490599961, 117480597107, 117430591574, 117150562907, 116520546288, 116520546282, 116480540169, 116470539963, 116440534646; y) QS-6AC-DFBAA, UDI/DI 00732094302073, Serial Numbers: 122200000715, 122190000632, 122130001859, 122130001858, 122130001857, 122020001892, 122020000512, 122020000511, 121340000499, 121320001535, 121320000290, 121140001779, 120440000212, 119250000555, 119170000486, 122430000520, 122430000521, 119130000111, 119270000118; z) QS-6AC-AFCXA, UDI/DI 00732094263862, Serial Numbers: 118070613220; aa) QS-6AC-CECAA, UDI/DI 00732094336801, Serial Numbers: 123010001116, 120450001427, 120450001426, 120450001425, 123350000876, 123450001519; bb) QS-6AC-CFCAA, UDI/DI 00732094263817, Serial Numbers: 117290578972; cc) QS-6AC-CFEAA, UDI/DI 00732094263800, Serial Numbers: 117430591575; dd) QS-6AC-ACAAB, UDI/DI 00732094263879, Serial Numbers: 123280000370, 123280000369, 123280000368, 123280000367, 123280000366, 123280000365, 123200001032, 123200001031, 123200001030, 123200001029, 123200001028, 123200001027, 123030001347, 123030001346, 123030001345, 123030001344, 123030001343, 123030001342, 123030001341, 123030001340, 123030001339, 123030001338, 123030001337, 123030001336, 122460001577, 122460001576, 122460001575, 122460001574, 122460001573, 121410001264, 121410001263, 121410001262, 121410001261, 121410001260, 121410001259, 121410001258, 121410001257, 121410001256, 121410001255, 121370000467, 121370000466, 121370000465, 121370000464, 121370000463, 121240001238, 121240001237, 121170000417, 121170000416, 121170000415, 121170000414, 121170000413, 121170000412, 121170000411, 121110000836, 121110000835, 121110000834, 121110000833, 121110000832, 121110000831, 121110000830, 121110000829, 121110000828, 121110000827, 121110000826, 121110000825, 121110000824, 121050000578, 121050000577, 121050000576, 121050000575, 121050000574, 118460000414, 118460000413, 118460000412, 118460000411, 118460000410, 118460000409, 118170632607, 118170632606, 118100617938, 118100617937, 118090616426, 118090616425, 118090616424, 117460595390, 117460595389, 117460595388, 117460595387, 117460595386, 117460595385, 117380587627, 117380587626, 117050553076, 117050553075, 117050553074, 116500544083, 116500544082, 116500544081, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123370000153, 123370000154, 123370000155, 123370000156; ee) QS-6AC-DDBAB, UDI/DI 00732094312966, Serial Numbers: 119350002685, 119100000503; ff) QS-6AC-DDBAC, UDI/DI 00732094312959, Serial Numbers: 119350002686; gg) QS-6AC-CDBXA, UDI/DI 00732094263831, Serial Numbers: 123190000068, 123110001251, 122090001000, 116470538496, 116470538495, 116470538494, 116470538493, 116470538492, 116470538491, 116340523788, 116340523787, 116340523786, 123400000105, 123450000611; hh) QS-6AC-DDBAA, UDI/DI 00732094312973, Serial Numbers: 119350002087, 119100000502; ii) QS-6AB-BXAXA, UDI/DI 00732094263916, Serial Numbers: 116110349242; jj) QS-6AB-CGAAB, UDI/DI 00732094263893, Serial Numbers: 122240001151, 120390000393, 118070613221; kk) QS-6AA-DEAXX, UDI/DI 00732094263923, Serial Numbers: 116190431279, 116190431277, 116190431275, 116190431273, 116190431271, 116190431269; ll) QS-6AB-CEAAA, UDI/DI 00732094263909, Serial Numbers: 119270000108, 119040000856, 117490600126, 123110000500; mm) QS-6AD-AEAAA, UDI/DI 00732094288940, Serial Numbers: 118490000214, 118490000213, 118490000212, 118490000211, 118270000503, 118270000502, 118270000501; nn) QS-6AD-BCAAX, UDI/DI 00732094263718, Serial Numbers: 116230451701; oo) QS-6AA-ACAAB, UDI/DI 00732094263947, Serial Numbers: 119240000738, 115510284694; pp) QS-6AA-DDAAB, UDI/DI 00732094263930, Serial Numbers: 116150390528; qq) QS6-ATTDX, UDI/DI 0081234502757021, Serial Numbers: 116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 116530546705, 116530547310, 116530547262, 116530547263, 117010549347, 117010549348, 117010549349, 117030551222, 117030551223, 117030551224, 117030551198, 117060553621, 117080554650, 117090555978, 117120556692, 117120556693, 117120556669, 117120556938, 117120556939, 117110556361, 117130560356, 117130559722, 117130559723, 117130559724, 117130559725, 117130560366, 117130560907, 117130560908, 117130560909, 117130559206, 117130559207, 117140562692, 117140561999, 117140562000, 117180567011, 117200568668, 117200568669, 117200569177, 117210570093, 117210570094, 117210570095, 117210570736, 117230572508, 117230572509, 117230572795, 117230572796, 117230572797, 117240573777, 117250575370, 117260576146, 117260576380, 117260576147, 117260576521, 117260576907, 117270577366, 117270577367, 117270577369, 117300580355, 117260576919, 117330582978, 117340583701, 117340583700, 117340583703, 117350584566, 117360584806, 117380586443, 117380586438, 117380586439, 117380586440, 117380587063, 117390588206, 117410590220, 117420591116, 117460595235, 117480597799, 117490599957, 117490599958, 117490599959, 117500601066, 117480597585, 117490599960, 117510602015, 117510602783, 118010604423, 118030607407, 118030607409, 118050609952, 118090615612, 118090616239, 118190635182, 118180633951, 118150626794, 118110620676, 118110620675, 118030607408, 118110620673, 118110620672, 118110620671, 118110620670, 118120622027, 118110620674, 116520545400, 116520545401, 118200637266, 118200637265, 118200637264, 118190635507, 118190635506, 118190635505, 118190636600, 118190636599, 118210638582, 118210638581, 118240001206, 118250002189, 118250002190, 118260000335, 118260000336, 118260000337, 118260000338, 118260000339, 118260000340, 118260000341, 118260000342, 118260000343, 118270000716, 118270000717, 118300001211, 118300001212, 118310000439, 118310000440, 118310001698, 118340000909, 118340000910, 118340000911, 118350000119, 118350000120, 118350000895, 118360000412, 118370000771, 118370000772, 118370001923, 118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119470001907, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 150160001505, 120230002008, 120230002009, 120230002010, 120230002011, 120230002012, 120230002013, 150160001506, 150160001507, 150160001508, 150160001509, 150160001510, 150160001511, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 150160001513, 150160001514, 150160001515, 150160001516, 150160001517, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 150160001518, 150160001519, 150160001520, 150160001521, 150160001522, 150160001523, 150160001524, 150160001525, 150160001526, 150160001527, 150160001528, 150160001529, 150160001530, 150160001531, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, EXCNORETURN, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 150160001532, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 8, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123310001377, 123310001378, 123330000777, 123330000778, 123330000779, 123350000286, 123350000287, 123350000288, 123350000289, 123380001337, 123380001338, 123410000814, 123410000815, 123430001155, 123430001156, 123430001157, 123430001158, 123430001159, 123430001160, 123430001161, 123430001162; rr) QS-6AA-XCAAA, UDI/DI 00732094326710, Serial Numbers: 122120000190, 122100001656, 122090001811, 122090001810, 122020001000, 122020000999, 122020000998, 121520000975, 121160002375, 120170000553, 120170000554, 122300000629; ss) QS6-MLTCX, UDI/DI 0081234502764821, Serial Numbers: 116080321499, 116100346607, 116130375989, 116130375990, 116130379805, 116210439189, 116210438778, 116230453065, 116230453067, 116250485173, 116240477775, 116260493401, 116240459074, 116270501516, 116270498867, 116280505345, 116290517124, 116290519660, 116300520391, 116320522163, 116320522164, 116320522165, 116330522667, 116330523071, 116340523724, 116350524070, 116380527757, 116410531127, 116480540910, 116490541437, 116490541641, 116520545376, 116530547261, 117030551128, 117040552523, 117050552696, 117110556421, 117110556410, 117140561569, 117170564846, 117160563413, 117170566130, 117180566599, 117190568194, 117190568195, 117210569780, 117210569781, 117230572912, 117250574779, 117260576265, 117260576266, 117280577952, 117270577275, 117300580503, 117330583101, 117370586229, 117370585824, 117390587807, 117470596277, 117470596278, 117510602013, 117510602014, 118020605911, 118030607257, 118030607726, 118070613217, 118100617591, 118180634595, 118180634594, 118150627077, 118150627076, 118160628070, 118140625630, 118120622030, 118130624174, 118110620680, 118110620681, 118190636335, 118190635558, 118250001741, 118270000718, 118270000719, 118270000720, 118270000721, 118270000722, 118290000378, 118290000379, 118290000380, 118290001179, 118310000441, 118310001116, 118350000122, 118350000590, 118370000778, 118370000779, 118390000402, 118410000880, 118420000601, 118420000602, 118420000603, 118430000952, 118430000953, 118440001585, 118490000218, 118500000650, 118500002165, 118500002166, 118520000908, 118520000909, 118520000910, 119040000855, 119050000688, 119050000689, 119070000660, 119070000661, 119100001181, 119120000288, 119120001592, 119120001593, 119200000582, 119220000667, 119250000564, 119250000565, 119250000566, 119250000567, 119250000568, 119250000569, 119270000450, 119270000451, 119270000452, 119280000613, 119320000060, 119330000161, 119340000677, 119340000678, 119350002913, 119350002914, 119350002915, 119350002916, 119350002917, 119350002918, 119350002919, 119350003338, 119350003339, 119370000198, 119370000199, 119370000200, 119370000201, 119370001057, 119370001058, 119400001644, 119400001645, 119400001646, 119400001647, 119400001648, 119400001649, 119400001650, 119400001651, 119460001807, 119460001808, 119480000257, 119480000258, 119510000666, 119510001674, 119520000618, 120020001161, 120080000361, 120130000350, 120130000351, 120140001044, 120180000985, 120180000986, 120330000901, 120330000902, 120330000903, 120390000399, 120430001822, 120450001901, 120470000596, 120530000380, 120530000381, 120530000382, 120530000383, 120530000384, 120530000385, 121040002695, 121060000885, 121060000886, 121070000470, 121070000471, 121070000472, 121070000473, 121070001276, 121070001277, 121080000530, 121090001941, 121090001942, 121130001102, 121130001103, 121140000283, 121140000284, 121140000285, 121160002372, 121160002373, 121160002374, 121190000640, 121200000019, 121200000020, 121200000021, 121200000022, 121200001237, 121200001238, 121200001239, 121220000152, 121220000153, 121220000154, 121220000163, 121230000162, 121240001241, 121290001061, 121290001062, 121300001865, 121300001877, 121310001017, 121350000322, 121350000323, 121350000324, 121350001471, 121360001294, 121360001295, 121370000469, 121370001278, 121370001279, 121390000796, 121430000260, 121450000287, 121450001402, 121450001403, 121480001495, 121520000984, 121520001599, 121520001600, 122010000983, 122020001212, 122020001213, 122020001214, 122020001215, 122040000385, 122050001248, 122050001249, 122060002362, 122060002363, 122090001804, 122090001805, 122110000027, 122120002575, 122120002576, 122120002577, 122140000068, 122190001152, 122190001153, 122190001154, 122190001155, 122190001156, 122190001157, 122190001158, 122190001159, 122190001160, 122190001161, 122230000221, 122240001156, 122240001157, 122240001158, 122240001491, 122290001139, 122340000213, 122380000699, 122390000780, 122410001720, 122430001370, 123010001027, 123010001028, 123010001029, 123030000270, 123040001234, 123040001235, 123040001929, 123070000717, 123070000718, 123080000641, 123080000642, 123110001327, 123190001330, 123230001869, 123280000406, 123280001081, 123300001828, 123300001829, 123300001830, 123320000984, 123350000290, 123430001163, 123430001164; tt) QS6-MTTCX, UDI/DI 0081234502766221, Serial Numbers: 116130382738, 116140389728, 116150390531, 116200435411, 116220448959, 116250480265, 116300520110, 116300520111, 116300520112, 116300520113, 116360525386, 116360525794, 116370526230, 116380528390, 116380528391, 116380527756, 116420532146, 116460538198, 116460538356, 116530546826, 116530546811, 116530546820, 116530546821, 116530546822, 116530546823, 116530546824, 116530546825, 117010548789, 117010548790, 117020550495, 117050553051, 117080555509, 117110556504, 117130560261, 117130560971, 117130560972, 117130560973, 117130560974, 117140562016, 117140562066, 117190567380, 117200568648, 117250574073, 117250574074, 117370585092, 117370585113, 117370585090, 117370585091, 117370585093, 117370585094, 117370585110, 117370585111, 117370585112, 117420590606, 117430591572, 117470596276, 117500601524, 117500601525, 117500601526, 117500601527, 118030607881, 117520603557, 117520603558, 117520603559, 117520603560, 117520603561, 118070612283, 118040607881, 118180634593, 118120622400, 118120622028, 118110620684, 118270000723, 118290000381, 118360000418, 118500002168, 119050000693, 119090000899, 119170000012, 119200000994, 119450000817, 120190000899, 120240000419, 120480001167, 121030000256, 121030000257, 121040002691, 121040002692, 121040002693, 121040002694, 121060000878, 121060000879, 121060000880, 121060000881, 121060000882, 121060000883, 121060000884, 121060000919, 121070002432, 121190000641, 121190000642, 121300001282, 121340000509, 121340000510, 121350001470, 121370002509, 121510001478, 121510001479, 121510001480, 121510001481, 122020000732; uu) QS-6AA-CDCAA, UDI/DI 00732094286021, Serial Numbers: 118180633960; vv) QS-6AA-DDCAA, UDI/DI 00817655021355, Serial Numbers: 117140561568; ww) QS-6BC-CGAAA, UDI/DI 00732094263589, Serial Numbers: 116190425280; xx) QS-6BC-CDCXA, UDI/DI 00732094263596, Serial Numbers: 116140389770; yy) QS-6BB-CFAAB, UDI/DI 00732094263626, Serial Numbers: 116170410170; zz) QS6-ATTD1, UDI/DI 0081234502756321, Serial Numbers: 116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 116230455578, 116230455580, 116230455582, 116230455584, 116230455588, 116310520897, 116310520898, 116230455586, 116310520896, 116320521690, 116320521865, 116330522902, 116330522848, 116330522849, 116340523648, 116350524130, 116370526975, 116400529514, 116400529515, 116400529516, 116400529517, 116400529518, 116390529090, 116370526974, 116400529519, 116400529520, 116400529521, 116400529522, 116400529523, 116400529920, 116400529921, 116400530088, 116400530553, 116400530028, 116420531722, 116420532142, 116430534054, 116430534055, 116450536077, 116450536208, 116460537576, 116460538355, 116460537453, 116470539394, 116490542247, 116490542248, 116510544247, 116510545330, 116510545331, 116520546402, 116520546401, 116520546230, 116520546403, 116520546400, 117050553073, 117060553950, 117080555092, 117090555749, 117090555843, 117090555865, 117090555866, 117090555867, 117110556362, 117110556363, 117110556289, 117110556290, 117120556937, 117120557454, 117120557458, 117120557459, 117120557460, 117130560125, 117130560428, 117130560970, 117140562012, 117150562725, 117140562010, 117140562011, 117150562893, 117160564733, 117170565765, 118210000029, 118210000030, 117200568387, 117200568404, 117190568245, 117190568246, 117190568247, 117190568248, 117190568249, 117200568664, 117200568665, 117200568666, 117210570494, 117220571853, 117220571854, 117220571855, 117220571856, 117240573477, 117250575043, 117250574851, 117260576250, 117290578774, 117290579353, 117300579812, 117300579810, 117320581838, 117310581538, 117330582979, 117350583853, 117350583854, 117340583699, 117350583855, 117340583702, 117350584009, 117350584025, 117350584041, 117350584042, 117350584043, 117360584752, 117360585080, 117370585583, 117380586304, 117380586303, 117380587697, 117380587478, 117380587698, 117410589631, 117400589312, 117410589632, 117410589633, 117430591573, 117440593332, 117440593333, 117440593334, 117440593335, 117440593336, 117440593337, 117430592467, 117430592468, 117470596323, 117470596320, 117470596321, 117470596322, 117470596324, 117470596325, 117490599956, 117490599050, 117480597582, 117500600631, 117500600630, 117500600632, 117500600633, 117520603148, 117510602771, 117520603149, 118010605331, 118030607571, 118030607572, 118030607406, 118050609192, 118050609228, 118060610911, 118060610912, 118070613219, 118090615613, 118090615614, 118090615615, 118100617471, 118100617472, 118110618490, 118180634182, 118150627494, 118150627493, 118150627068, 118160628174, 118140626434, 118140626433, 118130624868, 118120622403, 118120622402, 118120622026, 118180634181, 118180635054, 118180635051, 118180635050, 118180634183, 118180635052, 118180635053, 118240001668, 118240001669, 118240001831, 118240001832, 118240001833, 118250001326, 118250001327, 118260000781, 118260000782, 118270000714, 118270000715, 118280001257, 118280001258, 118280001259, 118280001260, 118280001261, 118290000376, 118290000377, 118290000867, 118290001241, 118290001242, 118290001243, 118320001185, 118340000905, 118340000906, 118340000907, 118340000908, 118350000117, 118350000118, 118360000051, 118360000052, 118360000053, 118360000054, 118360000055, 118360000056, 118360000057, 118360000058, 118360000059, 118360000518, 118360000519, 118360000520, 118360000521, 118360000522, 118360000523, 118360000524, 118360000525, 118380001931, 118380001932, 118390000386, 118390000387, 118390000388, 118390000389, 118390000390, 118400000207, 118400000208, 118400000209, 118400000210, 118400000211, 118400000698, 118400000699, 118400000700, 118430001304, 118430001305, 118430001306, 118450001177, 118460001582, 118460001583, 118470000260, 118470000261, 118500000639, 118500000640, 118500000641, 118500000642, 118500000643, 118520000905, 119040000854, 119050000681, 119050000682, 119050000683, 119050000684, 119060001359, 119060001360, 119070000214, 119070000215, 119070000216, 119080000186, 119080000187, 119080000188, 119080000189, 119110000756, 119120001149, 119120001150, 119120001151, 119120001152, 119160000318, 119160000319, 119170000425, 119200001274, 119200001822, 119210001020, 119210001021, 119220000664, 119220000665, 119220001048, 119220001049, 119230002429, 119230002430, 119230002431, 119250000553, 119250001410, 119250001411, 119250001414, 119250001415, 119260000126, 119260000127, 119280001372, 119280001749, 119280001750, 119310000245, 119310000246, 119310000247, 119310000248, 119310001358, 119310001359, 119310001360, 119330000157, 119330000808, 119330000809, 119380001356, 119380001357, 119380001358, 119380001359, 119380001360, 119380001361, 119380001362, 119380001363, 119380001364, 119380001365, 119380001366, 119390001988, 119390001989, 119390001990, 119390000615, 119400000248, 119400000249, 119400000250, 119400000254, 119400000255, 119400001290, 119400001291, 119400001292, 119400001293, 119400001294, 119400001295, 119430001817, 119430001818, 119430001819, 119430001820, 119430001821, 119430001822, 119430001823, 119450001900, 119450001901, 119450001902, 119450001903, 119450001904, 119450001905, 119450001906, 119460001072, 119460001073, 119490000495, 119490000496, 119490000497, 119490000498, 119490000499, 119490000500, 119500000110, 119500000529, 119500000530, 119500000531, 119500000532, 119500000533, 119500001528, 119500001529, 119500001530, 119500001531, 119500001532, 119510000661, 119510000662, 119510000663, 119510000664, 119510000665, 119510001185, 119510001186, 119510001187, 119510001188, 119510001189, 119520000621, 119520000622, 119520000623, 120010000754, 120010000755, 120020001163, 120030000546, 120040000641, 120040000642, 120040000643, 120050000441, 120050000442, 120050000443, 120060000937, 120070001199, 120070001200, 120080000836, 120090001324, 120090001325, 120090001326, 120090001327, 120100000623, 120100000624, 120100000625, 120100000626, 120100001903, 120100001904, 120100001905, 120100001906, 120100001907, 120100001908, 120110002511, 120120000635, 120120000636, 120120000637, 120120000638, 120120001441, 120120001442, 120120001443, 120130000345, 120130000346, 120130000347, 120130001075, 120130001076, 120130001077, 120130001078, 120150002418, 120150002419, 120160001488, 120160001489, 120160001490, 120160001491, 120160001492, 120160001493, 120160001494, 120160001495, 120160001496, 120160001497, 120160001498, 120160001499, 120190000898, 120200001394, 120200001395, 120230001624, 120230001625, 120230001626, 120230002014, 120230002015, 120230002016, 120230002017, 120230002018, 120230002019, 120230002020, 120230002021, 120230002022, 120230002023, 120230002024, 120230002025, 120250000217, 120250000218, 120250000219, 120250000220, 120250000221, 120250000222, 120260000166, 120260000167, 120260000168, 120260000169, 120300000078, 120300001450, 120300001451, 120310001587, 120310001588, 120320000359, 120320000360, 120320000361,
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

โš ๏ธ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Baxter Healthcare Corporation
Reason for Recall:
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)

Product Codes/Lot Numbers:

a) QS6-BXXCS, UDI/DI 00732094263176, Serial Numbers: 116350524925, 116490541255; b) QS-6CC-DGCXX, UDI/DI 00732094308716, Serial Numbers: 119050000134; c) QS-6CC-DFCXX, UDI/DI 00732094308723, Serial Numbers: 122290000606, 122230001869, 122230001868, 122150001605, 122150001604, 122090000843, 119310001134, 119240000440, 122430000522, 122430000523, 119050000135; d) QS-6JB-AXAXA, UDI/DI 00732094263206, Serial Numbers: 123170000019; e) QS6-BLXCX, UDI/DI 0081234502761721, Serial Numbers: 116090330912, 116100344488, 116100344490, 116140389225, 116150394312, 116180422821, 116180422823, 116210442892, 116220445992, 116230451848, 116230455471, 116260496356, 116310521226, 116310521294, 116310521295, 116340523119, 116370526978, 116400530719, 116500543975, 116520546015, 117090555819, 117120557453, 117240573603, 117240573604, 117240573605, 117240573606, 117250575355, 117250575356, 117310581182, 117320582007, 117330583105, 117330583106, 117420591117, 117480596687, 117510602012, 117520603268, 118020605912, 118040608668, 118050610650, 118180633950, 118180633951, 118250001740, 118210638580, 118360000413, 118360000414, 118360000415, 118400000214, 119090001180, 119170000426, 119200000235, 119250000559, 119350003341, 119350003342, 119400001642, 119400001643, 119390002403, 119450000815, 119470000523, 119470000524, 120190001489, 120340001206, 120370000113, 120390000395, 120450000603, 117380587441, 121040002696, 121320000296, 121400000048, 121420000470; f) QS6-BLXC1, UDI/DI 0081234502760021, Serial Numbers: 116110351990, 116170411313, 116180422820, 116190425267, 116200431781, 116200435830, 116200435832, 116210440257, 116210442845, 116220445031, 116220447262, 116220447261, 116220448956, 116240457509, 116240461442, 116240461206, 116250486048, 116250485976, 116250489753, 116260496350, 116260496357, 116260496358, 116260496359, 116270498882, 116280504766, 116280504767, 116280505422, 116290511314, 116290511315, 116290516779, 116300519942, 116300520698, 116310521231, 116310521175, 116320522055, 116330522666, 116340523645, 116370526300, 116370526302, 116380527090, 116370526980, 116390528637, 116380528395, 116390529243, 116390529244, 116390529289, 116390529290, 116390529245, 116390529246, 116400530260, 116430534181, 116440534647, 116440535722, 116450535995, 116460537454, 116460537582, 116490541890, 116500544101, 116500544003, 116510545088, 116520546283, 116530547307, 116530547308, 116530547309, 116520546501, 116530547394, 117010549346, 117020550273, 117040551450, 117030550903, 117050552567, 117080554660, 117110556288, 117120556595, 117140562002, 117170565229, 117170566105, 117230572559, 117230572529, 117230572792, 117230572972, 117240573048, 117240573453, 117240573579, 117280577601, 117290579316, 117300580356, 117320581836, 117320581837, 117320582120, 117380587062, 117390588108, 117450593979, 117450593976, 117450593977, 117450593978, 117480597797, 117480597798, 117480597583, 117480597584, 117520603269, 117520603562, 118040607784, 118090615610, 118090615611, 118140626430, 118150627079, 118160628175, 118150627075, 118150627074, 118150627073, 118150627072, 118150627071, 118150627070, 118150627069, 118120623174, 118180633959, QS6-BLXC1, 118180634187, 118310001237, 118340000912, 118340000913, 118340000914, 118370000773, 118380001940, 118460001584, 118480000810, 118490000217, 118520000406, 119040000078, 119110000757, 119150000254, 119160000043, 119190000970, 119250000554, 119280001984, 119290000535, 119500001105, 120020000304, 120100001917, 120220001572, 120220001573, 120230001261, 120320000243, 120320000244, 120300000912, 120360001047, 121070000465, 121070001280, 121100002344, 121100002345, 121130001104, 121180000761, 121340000883, 121370002510, 121390000795, 121460001255, 122200001819, 122480002102, 123300001831; g) QS-6AC-XXAXX, UDI/DI 00732094301076, Serial Numbers: 123240000013, 123240000012, 123240000011, 123240000010, 123240000009, 120400002601, 120400002600, 120400002599, 120400002598, 120400002597, 120210000914, 120210000913, 120210000912, 120210000911, 120210000910, 120210000909, 120210000908, 120210000907, 120210000906, 120210000905, 120210000904, 120210000903, 119330001329, 119330001328, 119330001327, 119330001326, 119330001325, 119330001324, 119330001323, 119320001019, 119320001018, 119320001017, 119320001016, 119320001015, 119180001173, 119180001172, 119180001171, 119180001170, 119110000755, 118430000951, 11840000949, 118430000948, 118430000949, 123310000826, 123310000827, 123310000828, 123310000829, 123310000830, 123430000320, 123430000321, 123430000322, 123430000323, 123430000324, 123430000325, 123430000326, 123430000327, 123430000328, 123430000329; h) QS-6AC-XXBXX, UDI/DI 00732094346633, Serial Numbers: 123040001807, 123040001806, 123040001805, 123040001804, 123040001803, 122510000875, 122510000874, 122510000873, 122510000872, 122510000871, 122480001730, 122480001729, 122480001728, 122480001727, 122480001726, 122250001966, 122250001965, 122250001964, 122250001963, 122250001962, 122240000488, 122240000487, 122240000486, 122240000485, 122240000484, 122160000349, 122160000348, 122160000347, 122160000346, 122160000345, 122010000998, 122010000997, 122010000996, 122010000995, 122010000994, 121490000353, 121490000352, 121490000351, 121490000350, 121490000349, 121320000685, 121320000684, 121320000683, 121320000682, 121320000681, 121090000175, 121090000174, 121090000173, 121090000172, 121090000171; i) QS-6AC-XXAXA, UDI/DI 00732094355314, Serial Numbers: 123400000592, 123400000593; j) QS6-AXTDS, UDI/DI 00812345027587, Serial Numbers: 116120372696; k) QS-6AC-AXAAA, UDI/DI 00732094263855, Serial Numbers: 118520000406; l) QS-6AC-CXBXA, UDI/DI 00732094263794, Serial Numbers: 116330522481; m) QS-6AC-DXAXA, UDI/DI 00732094263756, Serial Numbers: 116070309986; n) QS-6AC-XXBXA, UDI/DI 00732094263732, Serial Numbers: 117380586614; o) QS6-MXTCS, UDI/DI 0081234502767921, Serial Numbers: 116150390529, 116210438777, 116530547233, 116530547234, 116530547235; p) QS-6AC-CGAAB, UDI/DI 00732094326604, Serial Numbers: 119470001903; q) QS-6AC-XAAXA, UDI/DI 00732094263749, Serial Numbers: 117280578329; r) QS-6AC-DEAAX, UDI/DI 00732094263787, Serial Numbers: 117120558685; s) QS-6AC-DFAAX, UDI/DI 00732094263763, 117160563895; t) QS-6AC-EEBXX, UDI/DI None, Serial Numbers: 118200636641; u) QS-6AC-CFBAB, UDI/DI 00732094318029, Serial Numbers: 123130002242; v) QS-6AC-CFAAA, UDI/DI 00732094263824, Serial Numbers: 122060000614, 121270000363, 117210570696; w) QS-6AC-CFBAA, UDI/DI 00732094318111, Serial Numbers: 123130000023, 123130000022, 123130000021, 123130000020, 123130000019, 123130000018, 122380000698, 121450000731, 121450000730, 123290000564, 123290000565; x) QS-6AC-DFAAA, UDI/DI 00732094263770, Serial Numbers: 118440001972, 119260000952, 119080001406, 119080001405, 118500002162, 118440001973, 118210638583, 118200636642, 118050610062, 118040608669, 117490599962, 117490599961, 117480597107, 117430591574, 117150562907, 116520546288, 116520546282, 116480540169, 116470539963, 116440534646; y) QS-6AC-DFBAA, UDI/DI 00732094302073, Serial Numbers: 122200000715, 122190000632, 122130001859, 122130001858, 122130001857, 122020001892, 122020000512, 122020000511, 121340000499, 121320001535, 121320000290, 121140001779, 120440000212, 119250000555, 119170000486, 122430000520, 122430000521, 119130000111, 119270000118; z) QS-6AC-AFCXA, UDI/DI 00732094263862, Serial Numbers: 118070613220; aa) QS-6AC-CECAA, UDI/DI 00732094336801, Serial Numbers: 123010001116, 120450001427, 120450001426, 120450001425, 123350000876, 123450001519; bb) QS-6AC-CFCAA, UDI/DI 00732094263817, Serial Numbers: 117290578972; cc) QS-6AC-CFEAA, UDI/DI 00732094263800, Serial Numbers: 117430591575; dd) QS-6AC-ACAAB, UDI/DI 00732094263879, Serial Numbers: 123280000370, 123280000369, 123280000368, 123280000367, 123280000366, 123280000365, 123200001032, 123200001031, 123200001030, 123200001029, 123200001028, 123200001027, 123030001347, 123030001346, 123030001345, 123030001344, 123030001343, 123030001342, 123030001341, 123030001340, 123030001339, 123030001338, 123030001337, 123030001336, 122460001577, 122460001576, 122460001575, 122460001574, 122460001573, 121410001264, 121410001263, 121410001262, 121410001261, 121410001260, 121410001259, 121410001258, 121410001257, 121410001256, 121410001255, 121370000467, 121370000466, 121370000465, 121370000464, 121370000463, 121240001238, 121240001237, 121170000417, 121170000416, 121170000415, 121170000414, 121170000413, 121170000412, 121170000411, 121110000836, 121110000835, 121110000834, 121110000833, 121110000832, 121110000831, 121110000830, 121110000829, 121110000828, 121110000827, 121110000826, 121110000825, 121110000824, 121050000578, 121050000577, 121050000576, 121050000575, 121050000574, 118460000414, 118460000413, 118460000412, 118460000411, 118460000410, 118460000409, 118170632607, 118170632606, 118100617938, 118100617937, 118090616426, 118090616425, 118090616424, 117460595390, 117460595389, 117460595388, 117460595387, 117460595386, 117460595385, 117380587627, 117380587626, 117050553076, 117050553075, 117050553074, 116500544083, 116500544082, 116500544081, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123370000153, 123370000154, 123370000155, 123370000156; ee) QS-6AC-DDBAB, UDI/DI 00732094312966, Serial Numbers: 119350002685, 119100000503; ff) QS-6AC-DDBAC, UDI/DI 00732094312959, Serial Numbers: 119350002686; gg) QS-6AC-CDBXA, UDI/DI 00732094263831, Serial Numbers: 123190000068, 123110001251, 122090001000, 116470538496, 116470538495, 116470538494, 116470538493, 116470538492, 116470538491, 116340523788, 116340523787, 116340523786, 123400000105, 123450000611; hh) QS-6AC-DDBAA, UDI/DI 00732094312973, Serial Numbers: 119350002087, 119100000502; ii) QS-6AB-BXAXA, UDI/DI 00732094263916, Serial Numbers: 116110349242; jj) QS-6AB-CGAAB, UDI/DI 00732094263893, Serial Numbers: 122240001151, 120390000393, 118070613221; kk) QS-6AA-DEAXX, UDI/DI 00732094263923, Serial Numbers: 116190431279, 116190431277, 116190431275, 116190431273, 116190431271, 116190431269; ll) QS-6AB-CEAAA, UDI/DI 00732094263909, Serial Numbers: 119270000108, 119040000856, 117490600126, 123110000500; mm) QS-6AD-AEAAA, UDI/DI 00732094288940, Serial Numbers: 118490000214, 118490000213, 118490000212, 118490000211, 118270000503, 118270000502, 118270000501; nn) QS-6AD-BCAAX, UDI/DI 00732094263718, Serial Numbers: 116230451701; oo) QS-6AA-ACAAB, UDI/DI 00732094263947, Serial Numbers: 119240000738, 115510284694; pp) QS-6AA-DDAAB, UDI/DI 00732094263930, Serial Numbers: 116150390528; qq) QS6-ATTDX, UDI/DI 0081234502757021, Serial Numbers: 116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 116530546705, 116530547310, 116530547262, 116530547263, 117010549347, 117010549348, 117010549349, 117030551222, 117030551223, 117030551224, 117030551198, 117060553621, 117080554650, 117090555978, 117120556692, 117120556693, 117120556669, 117120556938, 117120556939, 117110556361, 117130560356, 117130559722, 117130559723, 117130559724, 117130559725, 117130560366, 117130560907, 117130560908, 117130560909, 117130559206, 117130559207, 117140562692, 117140561999, 117140562000, 117180567011, 117200568668, 117200568669, 117200569177, 117210570093, 117210570094, 117210570095, 117210570736, 117230572508, 117230572509, 117230572795, 117230572796, 117230572797, 117240573777, 117250575370, 117260576146, 117260576380, 117260576147, 117260576521, 117260576907, 117270577366, 117270577367, 117270577369, 117300580355, 117260576919, 117330582978, 117340583701, 117340583700, 117340583703, 117350584566, 117360584806, 117380586443, 117380586438, 117380586439, 117380586440, 117380587063, 117390588206, 117410590220, 117420591116, 117460595235, 117480597799, 117490599957, 117490599958, 117490599959, 117500601066, 117480597585, 117490599960, 117510602015, 117510602783, 118010604423, 118030607407, 118030607409, 118050609952, 118090615612, 118090616239, 118190635182, 118180633951, 118150626794, 118110620676, 118110620675, 118030607408, 118110620673, 118110620672, 118110620671, 118110620670, 118120622027, 118110620674, 116520545400, 116520545401, 118200637266, 118200637265, 118200637264, 118190635507, 118190635506, 118190635505, 118190636600, 118190636599, 118210638582, 118210638581, 118240001206, 118250002189, 118250002190, 118260000335, 118260000336, 118260000337, 118260000338, 118260000339, 118260000340, 118260000341, 118260000342, 118260000343, 118270000716, 118270000717, 118300001211, 118300001212, 118310000439, 118310000440, 118310001698, 118340000909, 118340000910, 118340000911, 118350000119, 118350000120, 118350000895, 118360000412, 118370000771, 118370000772, 118370001923, 118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119470001907, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 150160001505, 120230002008, 120230002009, 120230002010, 120230002011, 120230002012, 120230002013, 150160001506, 150160001507, 150160001508, 150160001509, 150160001510, 150160001511, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 150160001513, 150160001514, 150160001515, 150160001516, 150160001517, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 150160001518, 150160001519, 150160001520, 150160001521, 150160001522, 150160001523, 150160001524, 150160001525, 150160001526, 150160001527, 150160001528, 150160001529, 150160001530, 150160001531, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, EXCNORETURN, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 150160001532, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 8, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123310001377, 123310001378, 123330000777, 123330000778, 123330000779, 123350000286, 123350000287, 123350000288, 123350000289, 123380001337, 123380001338, 123410000814, 123410000815, 123430001155, 123430001156, 123430001157, 123430001158, 123430001159, 123430001160, 123430001161, 123430001162; rr) QS-6AA-XCAAA, UDI/DI 00732094326710, Serial Numbers: 122120000190, 122100001656, 122090001811, 122090001810, 122020001000, 122020000999, 122020000998, 121520000975, 121160002375, 120170000553, 120170000554, 122300000629; ss) QS6-MLTCX, UDI/DI 0081234502764821, Serial Numbers: 116080321499, 116100346607, 116130375989, 116130375990, 116130379805, 116210439189, 116210438778, 116230453065, 116230453067, 116250485173, 116240477775, 116260493401, 116240459074, 116270501516, 116270498867, 116280505345, 116290517124, 116290519660, 116300520391, 116320522163, 116320522164, 116320522165, 116330522667, 116330523071, 116340523724, 116350524070, 116380527757, 116410531127, 116480540910, 116490541437, 116490541641, 116520545376, 116530547261, 117030551128, 117040552523, 117050552696, 117110556421, 117110556410, 117140561569, 117170564846, 117160563413, 117170566130, 117180566599, 117190568194, 117190568195, 117210569780, 117210569781, 117230572912, 117250574779, 117260576265, 117260576266, 117280577952, 117270577275, 117300580503, 117330583101, 117370586229, 117370585824, 117390587807, 117470596277, 117470596278, 117510602013, 117510602014, 118020605911, 118030607257, 118030607726, 118070613217, 118100617591, 118180634595, 118180634594, 118150627077, 118150627076, 118160628070, 118140625630, 118120622030, 118130624174, 118110620680, 118110620681, 118190636335, 118190635558, 118250001741, 118270000718, 118270000719, 118270000720, 118270000721, 118270000722, 118290000378, 118290000379, 118290000380, 118290001179, 118310000441, 118310001116, 118350000122, 118350000590, 118370000778, 118370000779, 118390000402, 118410000880, 118420000601, 118420000602, 118420000603, 118430000952, 118430000953, 118440001585, 118490000218, 118500000650, 118500002165, 118500002166, 118520000908, 118520000909, 118520000910, 119040000855, 119050000688, 119050000689, 119070000660, 119070000661, 119100001181, 119120000288, 119120001592, 119120001593, 119200000582, 119220000667, 119250000564, 119250000565, 119250000566, 119250000567, 119250000568, 119250000569, 119270000450, 119270000451, 119270000452, 119280000613, 119320000060, 119330000161, 119340000677, 119340000678, 119350002913, 119350002914, 119350002915, 119350002916, 119350002917, 119350002918, 119350002919, 119350003338, 119350003339, 119370000198, 119370000199, 119370000200, 119370000201, 119370001057, 119370001058, 119400001644, 119400001645, 119400001646, 119400001647, 119400001648, 119400001649, 119400001650, 119400001651, 119460001807, 119460001808, 119480000257, 119480000258, 119510000666, 119510001674, 119520000618, 120020001161, 120080000361, 120130000350, 120130000351, 120140001044, 120180000985, 120180000986, 120330000901, 120330000902, 120330000903, 120390000399, 120430001822, 120450001901, 120470000596, 120530000380, 120530000381, 120530000382, 120530000383, 120530000384, 120530000385, 121040002695, 121060000885, 121060000886, 121070000470, 121070000471, 121070000472, 121070000473, 121070001276, 121070001277, 121080000530, 121090001941, 121090001942, 121130001102, 121130001103, 121140000283, 121140000284, 121140000285, 121160002372, 121160002373, 121160002374, 121190000640, 121200000019, 121200000020, 121200000021, 121200000022, 121200001237, 121200001238, 121200001239, 121220000152, 121220000153, 121220000154, 121220000163, 121230000162, 121240001241, 121290001061, 121290001062, 121300001865, 121300001877, 121310001017, 121350000322, 121350000323, 121350000324, 121350001471, 121360001294, 121360001295, 121370000469, 121370001278, 121370001279, 121390000796, 121430000260, 121450000287, 121450001402, 121450001403, 121480001495, 121520000984, 121520001599, 121520001600, 122010000983, 122020001212, 122020001213, 122020001214, 122020001215, 122040000385, 122050001248, 122050001249, 122060002362, 122060002363, 122090001804, 122090001805, 122110000027, 122120002575, 122120002576, 122120002577, 122140000068, 122190001152, 122190001153, 122190001154, 122190001155, 122190001156, 122190001157, 122190001158, 122190001159, 122190001160, 122190001161, 122230000221, 122240001156, 122240001157, 122240001158, 122240001491, 122290001139, 122340000213, 122380000699, 122390000780, 122410001720, 122430001370, 123010001027, 123010001028, 123010001029, 123030000270, 123040001234, 123040001235, 123040001929, 123070000717, 123070000718, 123080000641, 123080000642, 123110001327, 123190001330, 123230001869, 123280000406, 123280001081, 123300001828, 123300001829, 123300001830, 123320000984, 123350000290, 123430001163, 123430001164; tt) QS6-MTTCX, UDI/DI 0081234502766221, Serial Numbers: 116130382738, 116140389728, 116150390531, 116200435411, 116220448959, 116250480265, 116300520110, 116300520111, 116300520112, 116300520113, 116360525386, 116360525794, 116370526230, 116380528390, 116380528391, 116380527756, 116420532146, 116460538198, 116460538356, 116530546826, 116530546811, 116530546820, 116530546821, 116530546822, 116530546823, 116530546824, 116530546825, 117010548789, 117010548790, 117020550495, 117050553051, 117080555509, 117110556504, 117130560261, 117130560971, 117130560972, 117130560973, 117130560974, 117140562016, 117140562066, 117190567380, 117200568648, 117250574073, 117250574074, 117370585092, 117370585113, 117370585090, 117370585091, 117370585093, 117370585094, 117370585110, 117370585111, 117370585112, 117420590606, 117430591572, 117470596276, 117500601524, 117500601525, 117500601526, 117500601527, 118030607881, 117520603557, 117520603558, 117520603559, 117520603560, 117520603561, 118070612283, 118040607881, 118180634593, 118120622400, 118120622028, 118110620684, 118270000723, 118290000381, 118360000418, 118500002168, 119050000693, 119090000899, 119170000012, 119200000994, 119450000817, 120190000899, 120240000419, 120480001167, 121030000256, 121030000257, 121040002691, 121040002692, 121040002693, 121040002694, 121060000878, 121060000879, 121060000880, 121060000881, 121060000882, 121060000883, 121060000884, 121060000919, 121070002432, 121190000641, 121190000642, 121300001282, 121340000509, 121340000510, 121350001470, 121370002509, 121510001478, 121510001479, 121510001480, 121510001481, 122020000732; uu) QS-6AA-CDCAA, UDI/DI 00732094286021, Serial Numbers: 118180633960; vv) QS-6AA-DDCAA, UDI/DI 00817655021355, Serial Numbers: 117140561568; ww) QS-6BC-CGAAA, UDI/DI 00732094263589, Serial Numbers: 116190425280; xx) QS-6BC-CDCXA, UDI/DI 00732094263596, Serial Numbers: 116140389770; yy) QS-6BB-CFAAB, UDI/DI 00732094263626, Serial Numbers: 116170410170; zz) QS6-ATTD1, UDI/DI 0081234502756321, Serial Numbers: 116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 116230455578, 116230455580, 116230455582, 116230455584, 116230455588, 116310520897, 116310520898, 116230455586, 116310520896, 116320521690, 116320521865, 116330522902, 116330522848, 116330522849, 116340523648, 116350524130, 116370526975, 116400529514, 116400529515, 116400529516, 116400529517, 116400529518, 116390529090, 116370526974, 116400529519, 116400529520, 116400529521, 116400529522, 116400529523, 116400529920, 116400529921, 116400530088, 116400530553, 116400530028, 116420531722, 116420532142, 116430534054, 116430534055, 116450536077, 116450536208, 116460537576, 116460538355, 116460537453, 116470539394, 116490542247, 116490542248, 116510544247, 116510545330, 116510545331, 116520546402, 116520546401, 116520546230, 116520546403, 116520546400, 117050553073, 117060553950, 117080555092, 117090555749, 117090555843, 117090555865, 117090555866, 117090555867, 117110556362, 117110556363, 117110556289, 117110556290, 117120556937, 117120557454, 117120557458, 117120557459, 117120557460, 117130560125, 117130560428, 117130560970, 117140562012, 117150562725, 117140562010, 117140562011, 117150562893, 117160564733, 117170565765, 118210000029, 118210000030, 117200568387, 117200568404, 117190568245, 117190568246, 117190568247, 117190568248, 117190568249, 117200568664, 117200568665, 117200568666, 117210570494, 117220571853, 117220571854, 117220571855, 117220571856, 117240573477, 117250575043, 117250574851, 117260576250, 117290578774, 117290579353, 117300579812, 117300579810, 117320581838, 117310581538, 117330582979, 117350583853, 117350583854, 117340583699, 117350583855, 117340583702, 117350584009, 117350584025, 117350584041, 117350584042, 117350584043, 117360584752, 117360585080, 117370585583, 117380586304, 117380586303, 117380587697, 117380587478, 117380587698, 117410589631, 117400589312, 117410589632, 117410589633, 117430591573, 117440593332, 117440593333, 117440593334, 117440593335, 117440593336, 117440593337, 117430592467, 117430592468, 117470596323, 117470596320, 117470596321, 117470596322, 117470596324, 117470596325, 117490599956, 117490599050, 117480597582, 117500600631, 117500600630, 117500600632, 117500600633, 117520603148, 117510602771, 117520603149, 118010605331, 118030607571, 118030607572, 118030607406, 118050609192, 118050609228, 118060610911, 118060610912, 118070613219, 118090615613, 118090615614, 118090615615, 118100617471, 118100617472, 118110618490, 118180634182, 118150627494, 118150627493, 118150627068, 118160628174, 118140626434, 118140626433, 118130624868, 118120622403, 118120622402, 118120622026, 118180634181, 118180635054, 118180635051, 118180635050, 118180634183, 118180635052, 118180635053, 118240001668, 118240001669, 118240001831, 118240001832, 118240001833, 118250001326, 118250001327, 118260000781, 118260000782, 118270000714, 118270000715, 118280001257, 118280001258, 118280001259, 118280001260, 118280001261, 118290000376, 118290000377, 118290000867, 118290001241, 118290001242, 118290001243, 118320001185, 118340000905, 118340000906, 118340000907, 118340000908, 118350000117, 118350000118, 118360000051, 118360000052, 118360000053, 118360000054, 118360000055, 118360000056, 118360000057, 118360000058, 118360000059, 118360000518, 118360000519, 118360000520, 118360000521, 118360000522, 118360000523, 118360000524, 118360000525, 118380001931, 118380001932, 118390000386, 118390000387, 118390000388, 118390000389, 118390000390, 118400000207, 118400000208, 118400000209, 118400000210, 118400000211, 118400000698, 118400000699, 118400000700, 118430001304, 118430001305, 118430001306, 118450001177, 118460001582, 118460001583, 118470000260, 118470000261, 118500000639, 118500000640, 118500000641, 118500000642, 118500000643, 118520000905, 119040000854, 119050000681, 119050000682, 119050000683, 119050000684, 119060001359, 119060001360, 119070000214, 119070000215, 119070000216, 119080000186, 119080000187, 119080000188, 119080000189, 119110000756, 119120001149, 119120001150, 119120001151, 119120001152, 119160000318, 119160000319, 119170000425, 119200001274, 119200001822, 119210001020, 119210001021, 119220000664, 119220000665, 119220001048, 119220001049, 119230002429, 119230002430, 119230002431, 119250000553, 119250001410, 119250001411, 119250001414, 119250001415, 119260000126, 119260000127, 119280001372, 119280001749, 119280001750, 119310000245, 119310000246, 119310000247, 119310000248, 119310001358, 119310001359, 119310001360, 119330000157, 119330000808, 119330000809, 119380001356, 119380001357, 119380001358, 119380001359, 119380001360, 119380001361, 119380001362, 119380001363, 119380001364, 119380001365, 119380001366, 119390001988, 119390001989, 119390001990, 119390000615, 119400000248, 119400000249, 119400000250, 119400000254, 119400000255, 119400001290, 119400001291, 119400001292, 119400001293, 119400001294, 119400001295, 119430001817, 119430001818, 119430001819, 119430001820, 119430001821, 119430001822, 119430001823, 119450001900, 119450001901, 119450001902, 119450001903, 119450001904, 119450001905, 119450001906, 119460001072, 119460001073, 119490000495, 119490000496, 119490000497, 119490000498, 119490000499, 119490000500, 119500000110, 119500000529, 119500000530, 119500000531, 119500000532, 119500000533, 119500001528, 119500001529, 119500001530, 119500001531, 119500001532, 119510000661, 119510000662, 119510000663, 119510000664, 119510000665, 119510001185, 119510001186, 119510001187, 119510001188, 119510001189, 119520000621, 119520000622, 119520000623, 120010000754, 120010000755, 120020001163, 120030000546, 120040000641, 120040000642, 120040000643, 120050000441, 120050000442, 120050000443, 120060000937, 120070001199, 120070001200, 120080000836, 120090001324, 120090001325, 120090001326, 120090001327, 120100000623, 120100000624, 120100000625, 120100000626, 120100001903, 120100001904, 120100001905, 120100001906, 120100001907, 120100001908, 120110002511, 120120000635, 120120000636, 120120000637, 120120000638, 120120001441, 120120001442, 120120001443, 120130000345, 120130000346, 120130000347, 120130001075, 120130001076, 120130001077, 120130001078, 120150002418, 120150002419, 120160001488, 120160001489, 120160001490, 120160001491, 120160001492, 120160001493, 120160001494, 120160001495, 120160001496, 120160001497, 120160001498, 120160001499, 120190000898, 120200001394, 120200001395, 120230001624, 120230001625, 120230001626, 120230002014, 120230002015, 120230002016, 120230002017, 120230002018, 120230002019, 120230002020, 120230002021, 120230002022, 120230002023, 120230002024, 120230002025, 120250000217, 120250000218, 120250000219, 120250000220, 120250000221, 120250000222, 120260000166, 120260000167, 120260000168, 120260000169, 120300000078, 120300001450, 120300001451, 120310001587, 120310001588, 120320000359, 120320000360, 120320000361,

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0705-2024

Related Recalls

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.

Nov 28, 2025 Infusion Pumps Nationwide View Details โ†’