AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
Class I - DangerousWhat Should You Do?
- Check if you have this product: A5410000053, A5410000054, A5411000439, A5411000446, A5411000447, A5411000448, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5410000100, A5410000107, A5410000134, A5411000184, A5410000039, A5411000140, A5411000142, A5411000314, A5411000342, A5411000347, A5411000349, A5410000007, A5411000017, A5411000315, A5411000331, A5411000332, A5411000463, A5411000141, A5411000144, A5411000539, A5411000541, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000019, A5411000400, A5411000401, A5411000540, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5411000041, A5411000079, A5411000024, A5411000032, A5411000083, A5411000038, A5411000132, A5411000571, A5411000573, A5411000050, A5411000088, A5411000247, A5411000070, A5411000078, A5411000082, A5411000476, A5411000478, A5411000480, A5411000482, A5411000489, A5411000490, A5411000563, A5411000582, A5411000154, A5411000156, A5411000404, A5411000500, A5411000501, A5411000589, A5411000591, A5411000583, A5411000236, A5411000155, A5411000151, A5411000191, A5411000192, A5411000194, A5411000193, A5411000249, A5411000052, A5411000185, A5411000237, A5411000030, A5411000397, A5411000587, A5411000499, A5411000503, A5411000504, A5411000574, A5411000584, A5411000348, A5411000193, A5411000268, A5411000498, A5411000502, A5411000509, A5411000403, A5411000153, A5411000233, A5411000235, A5411000318, A5411000398, A5411000538, A5411000371, A5410000043, A5411000181, A5411000158, A5411000513, A5411000514, A5411000152, A5411000548, A5411000553, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000468, A5411000469, A5411000470, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000533, A5411000537, A5411000536, A5411000159, A5410000038, A5411000148, A5411000149, A5411000134, A5411000405, A5411000120, A5411000125, A5411000372, A5411000147, A5411000588, A5411000039, A5411000117, A5411000121, A5411000333, A5411000334, A5411000377, A5411000040, A5411000240, A5411000593, A5411000594, A5411000085, A5411000419, A5411000097, A5411000281, A5411000278, A5411000279, A5411000280, A5411000492, A5411000282, A5411000245, A5411000277, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000399, A5411000491, A5411000493. A5411000524, A5411000497, A5411000534, A5411000526, A5411000535, A5411000122, A5411000575, A5411000576, A5411000577, A5411000495, A5411000578, A5410000044, A5411000037, A5411000241, A5411000246, A5411000108, A5411000110, A5411000114, A5411000312, A5411000074, A5411000080, A5411000522, A5411000033, A5411000139, A5411000543, A5411000182, A5411000190, A5411000021, A5411000374, A5411000218, A5411000572, A5411000084, A5411000098, A5411000238, A5411000116, A5411000408, A5411000409, A5410000042, A5410000023, A5411000544, A5411000580, A5411000581, A5411000545, A5411000546, A5411000547, A5411000579, A5411000337, A5411000338, A5411000340, A5411000341, A5411000475, A5411000549, A5411000373, A5411000420, A5410000133, A5410000117, A5410000115, A5410000079, A5410000131, A5410000066, A5410000132, A5410000114, A5410000082, A5410000116, A5411000025, A5411000523, A5411000525, A5411000590, A5411000592, A5411000263, A5411000309, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000363, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000034, A5411000081, A5411000146, A5411000092, A5411000093, A5411000407, A5411000026, A5411000068, A5411000367, A5411000368, A5411000465, A5411000060, A5411000131, A5411000018, A5411000100, A5411000515, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000343, A5411000285, A5411000311, A5411000375, A5411000062, A5411000136, A5411000179, A5411000178, A5411000421, A5411000427, A5411000376
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AGFA Healthcare Corp.
- Reason for Recall:
- The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
Product Codes/Lot Numbers:
A5410000053, A5410000054, A5411000439, A5411000446, A5411000447, A5411000448, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5410000100, A5410000107, A5410000134, A5411000184, A5410000039, A5411000140, A5411000142, A5411000314, A5411000342, A5411000347, A5411000349, A5410000007, A5411000017, A5411000315, A5411000331, A5411000332, A5411000463, A5411000141, A5411000144, A5411000539, A5411000541, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000019, A5411000400, A5411000401, A5411000540, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5411000041, A5411000079, A5411000024, A5411000032, A5411000083, A5411000038, A5411000132, A5411000571, A5411000573, A5411000050, A5411000088, A5411000247, A5411000070, A5411000078, A5411000082, A5411000476, A5411000478, A5411000480, A5411000482, A5411000489, A5411000490, A5411000563, A5411000582, A5411000154, A5411000156, A5411000404, A5411000500, A5411000501, A5411000589, A5411000591, A5411000583, A5411000236, A5411000155, A5411000151, A5411000191, A5411000192, A5411000194, A5411000193, A5411000249, A5411000052, A5411000185, A5411000237, A5411000030, A5411000397, A5411000587, A5411000499, A5411000503, A5411000504, A5411000574, A5411000584, A5411000348, A5411000193, A5411000268, A5411000498, A5411000502, A5411000509, A5411000403, A5411000153, A5411000233, A5411000235, A5411000318, A5411000398, A5411000538, A5411000371, A5410000043, A5411000181, A5411000158, A5411000513, A5411000514, A5411000152, A5411000548, A5411000553, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000468, A5411000469, A5411000470, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000533, A5411000537, A5411000536, A5411000159, A5410000038, A5411000148, A5411000149, A5411000134, A5411000405, A5411000120, A5411000125, A5411000372, A5411000147, A5411000588, A5411000039, A5411000117, A5411000121, A5411000333, A5411000334, A5411000377, A5411000040, A5411000240, A5411000593, A5411000594, A5411000085, A5411000419, A5411000097, A5411000281, A5411000278, A5411000279, A5411000280, A5411000492, A5411000282, A5411000245, A5411000277, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000399, A5411000491, A5411000493. A5411000524, A5411000497, A5411000534, A5411000526, A5411000535, A5411000122, A5411000575, A5411000576, A5411000577, A5411000495, A5411000578, A5410000044, A5411000037, A5411000241, A5411000246, A5411000108, A5411000110, A5411000114, A5411000312, A5411000074, A5411000080, A5411000522, A5411000033, A5411000139, A5411000543, A5411000182, A5411000190, A5411000021, A5411000374, A5411000218, A5411000572, A5411000084, A5411000098, A5411000238, A5411000116, A5411000408, A5411000409, A5410000042, A5410000023, A5411000544, A5411000580, A5411000581, A5411000545, A5411000546, A5411000547, A5411000579, A5411000337, A5411000338, A5411000340, A5411000341, A5411000475, A5411000549, A5411000373, A5411000420, A5410000133, A5410000117, A5410000115, A5410000079, A5410000131, A5410000066, A5410000132, A5410000114, A5410000082, A5410000116, A5411000025, A5411000523, A5411000525, A5411000590, A5411000592, A5411000263, A5411000309, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000363, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000034, A5411000081, A5411000146, A5411000092, A5411000093, A5411000407, A5411000026, A5411000068, A5411000367, A5411000368, A5411000465, A5411000060, A5411000131, A5411000018, A5411000100, A5411000515, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000343, A5411000285, A5411000311, A5411000375, A5411000062, A5411000136, A5411000179, A5411000178, A5411000421, A5411000427, A5411000376
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1698-2017
Related Recalls
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
AGFA Healthcare
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
AGFA Healthcare
A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.