Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00884838104594; Serial Numbers:0Y5Z-7FHX-N 5H20-1DNN-E 1762-74NU-5 1C0V-08NR-0 6U53-30PD-1 6M5J-0JLM-H 2M2G-15LB-E 4U3A-3JGK-K 0439-16GM-G 3A1T-22HW-U 534U-57JE-Y 0D6U-5ZH1-D 3H5C-6JK9-X 3K0C-3EH3-H 3Z47-12JD-V 524N-43JR-2 5N40-2RHR-N 1331-5BNT-B 1V4F-34MB-G 1B4R-37N1-3 6D3L-28MC-M 7Y52-29H4-L 7Y5Z-7FHX-F 1X6W-21KC-W 6278-09GU-Y 2C6N-3KLU-C 3E5Y-32PN-4 5T2L-2TP9-V 021Z-1WJ2-5 1W6W-21KC-Z 7L3H-46MR-L 194D-2YHB-T 1Y7A-49M4-6 2Z3C-1AHM-3 4T51-53NK-A 1P4A-44NB-V 3B5M-55J9-5 5V57-0HN3-J 7V5Z-7FHX-R 224B-2HJF-F 5G1G-01JC-Z 6Y7F-06MT-0 676T-6XMZ-M 5F1G-01JC-2 5K2B-6DHP-4 5T45-7ELE-C 0V7B-4EJH-A 1F23-36KM-0 2C50-6KKD-R 3107-4RG3-6 3X5B-1NH8-2 6U32-24GX-0 5K2L-2TP9-D 4T2R-6HHJ-D 613L-28MC-T 7K21-0XNW-C 062U-1VNP-B 5M78-09GU-6 6226-14LG-X 0V6R-0PLF-7 5K72-2NL7-J 7G21-0XNW-M 077M-7JG6-L 2R4Y-5JHY-8 7Z4E-0EG2-N 1X2J-6LPP-R 1Y0A-64MU-A 0Z3E-41PZ-K 327Y-2CJW-6 3979-6CPV-0 2150-6KKD-T 4E6Z-70HU-B 1H3G-4UJL-D 2A75-27LY-3 3X3J-5PP3-5 4V7G-0BLD-8 567W-7BG9-5 5K6K-0RGF-L 6F2V-1BLC-W 0106-0UH7-D 1T1M-1TLH-F 5N2E-2FMY-1 057M-7JG6-U 0M5T-3FHA-Y 4B7K-7MPL-Y 4J2R-6HHJ-2 6H7F-06MT-7 184A-44NB-8 2518-4CLX-9 4Y40-2RHR-Z 5Y6J-3HL1-E 241K-18LJ-K 3R04-4ZPR-B 5B5G-0ZNF-T 4N77-1HM0-D 7W49-4XM7-M 723D-20JM-C 2V2W-3VM1-X 4T12-4BPG-8 5V3L-28MC-C 6J2K-47P7-C 2975-27LY-6 2E48-7GN2-3 2K0X-0TLA-F 302F-7YK1-P 3215-4JK4-E 3B05-6RJX-W 530G-60JV-Z 5843-5RM5-X 5J6K-0RGF-P 5U6T-6XMZ-X 684L-2BNM-Y 6K5U-66H9-G 743H-46MR-4 783K-6VGP-M 7F1U-7TJA-7 7U09-3WPK-T 0Z69-7VM6-F 1063-19MD-6 114M-03P1-2 1Y1E-50P2-J 2P5C-6JK9-C 7P27-0CKW-N 0J71-6UGD-Z 1H2D-0NNG-K 1X0A-64MU-D 3D1B-0ALR-A 620Z-2DMM-Y 6A3F-0KN0-B 0B5K-5AGH-7 333Y-7ZPB-9 6U33-3MMP-A 2U6M-2XHV-0 5F72-2NL7-Y 5K53-30PD-P 2J0X-0TLA-J 5034-61K2-8 6W2Z-7NPM-G 136A-1PJ5-1 3J5B-1NH8-3 4867-5XN6-H 6573-5WKF-6 017L-0VKT-B 0A31-5BNT-P 2J36-04K8-W 5D5J-0JLM-A 1A7A-49M4-2 0W02-1FHE-1 140F-4MHC-8 0856-68PX-Z 3R4K-7WMK-F 4G2R-6HHJ-8 7Y0V-08NR-4 027J-7LPC-9 1B0T-7AHH-U 2A1W-48PE-A 3W0K-6GLT-1 4R2H-3YNZ-B 5B72-2NL7-A 0K6R-0PLF-Z 3L13-0MNA-A 6255-58M8-0 065K-5AGH-N 156F-39G4-Z 277T-5KGZ-J 2907-4RG3-F 4E6B-2ZKV-W 5F29-2WG5-2 7L1H-5NMA-T 7N27-0CKW-T 1F4C-40KU-1 1208-4DL4-W 4R0G-60JV-1 5472-2NL7-Z 5R10-2GGN-6 7E1H-5NMA-B 7G6C-3BNE-3 3T5P-0YG8-Y 0V4F-34MB-H 3W4N-43JR-N 4R1C-1EGA-C 4Z5G-0ZNF-Y 5T5A-26K6-0 761Z-1WJ2-J 007B-4EJH-V 2F5M-55J9-U 2T2T-05HF-5 440L-4FL0-9 4V43-5RM5-5 5F6T-6XMZ-Y 711U-7TJA-H 4W2L-2TP9-K 0H63-5EHN-Y 1K01-1FHE-A 0F69-1PJ5-D 3L46-12JD-B 7A09-64MU-F 6419-6NGR-N 165D-5VMH-D 286M-3KLU-7 4W7R-5KGZ-0 5G1Y-1WJ2-5 6V52-30PD-D 726U-52P8-7 781H-1KG1-A 295M-4LGG-B 687V-7BG9-D 1Y1W-2MNL-F 776C-4TL3-N 3913-59N8-2 3H6V-21KC-D 4P5G-10GT-2 1E5N-0YG8-G 4H2B-5YJP-0 5030-5BNT-Z 5Y5U-2PJT-E 6M0P-3TLN-A 1Z0M-0FKE-V 3161-74NU-4 7127-6MKH-8 0X4G-0GN9-U 1D5N-0YG8-K 1W1D-50P2-7 1N5L-55J9-M 3204-6RJX-6 454X-5JHY-E 4R5J-5AGH-B 5V2K-2TP9-4 7U76-1HM0-D 3W35-04K8-C 604P-37N1-E 6939-3JGK-K 3T0L-0FKE-U 637V-7BG9-W 256D-1JPH-X 2M1B-1EGA-6 4H2L-1RHT-2 1K5L-55J9-Y 250N-17M9-D 4Z68-7VM6-U 5T2K-2TP9-A 1F4H-1CJJ-L 380K-4FL0-D 6R70-6UGD-N 6Y1L-1TLH-A 6Z1H-1KG1-6 003W-3UN7-M 0302-5TLL-M 1L48-4XM7-2 452Y-7NPM-6 571Y-1WJ2-0 7E2A-6DHP-0 3846-12JD-F 0G7A-4EJH-U 724E-34MB-4 1T36-4KHG-B 402H-6LPP-V 422Y-7NPM-F 0169-1PJ5-P 2L7D-2UGW-W 1W5M-4LGG-K 2215-5DJ6-4 4843-77KZ-X 5L74-27LY-H 1975-1LMN-R 7G76-1HM0-B 1T6M-3KLU-M 2D3V-3PJ8-1 3951-29H4-6 093T-6YM2-4 0P5D-5VMH-V 6X1X-3CH6-V 2015-5DJ6-A 5Z39-3JGK-J 3P7G-7CNC-6 5210-4GJY-8 5K5E-1YML-9 670P-3TLN-L 3L7E-06MT-G 6T49-44NB-Z 7U02-5TLL-9 0H4B-40KU-B 131T-7TJA-0 0N4C-2YHB-2 0W50-53NK-L 1B2M-79HL-2 1V0N-17M9-C 2479-49M4-2 2T13-59N8-K 3A3P-51MJ-0 3M12-0MNA-N 475G-10GT-J 610R-7AHH-2 650D-63JK-E 6L1L-1TLH-8 7D76-1HM0-L 7Y60-5UGY-J 4845-54M3-Y 5L5X-32PN-Z 2X46-12JD-H 0X5N-0YG8-4 505A-1NH8-6 3P2H-6LPP-P 4Z5A-1NH8-A 6D6U-52P8-7 7D1F-01JC-M 787B-1XPT-M 347K-0VKT-E 4R5V-11KG-Z 0N1E-7HJU-5 1F5C-7UMF-A 387Z-71KX-P 5T39-3JGK-4 715F-0ZNF-4 6P62-19MD-B 635Z-2KH5-4 092D-2FMY-W 0A4G-0GN9-K 1H0C-69LP-U 2J16-1MHK-9 2U4U-45K5-5 4E2E-7YK1-V 6C2N-0WPA-D 6N62-19MD-E 2205-0UH7-P 2M1A-0ALR-2 2T4U-45K5-8 3C5R-3FHA-5 425G-10GT-1 0D0M-4AH2-X 073G-46MR-H 145L-55J9-B 4Y55-68PX-8 5C19-6NGR-Z 6D3Z-2RHR-8 162M-79HL-H 6521-07LZ-0 7N69-1PJ5-H 191D-50P2-0 4P5V-11KG-2 661U-5LH0-D 7F0U-08NR-0 2A24-5CKL-R 5F5X-32PN-E 0U18-2JPY-C 386B-3BNE-E 714V-7RPJ-P 7676-1HM0-9 094B-40KU-3 0V1T-7TJA-T 0V4H-1CJJ-H 6H1X-3CH6-Z 0V75-1LMN-3 3B54-58M8-P 5674-27LY-V 5F1P-6PKN-Y 5K1J-18LJ-J 283A-13JG-H 4630-5BNT-E 4N5A-1NH8-5 5P3N-67ME-9 6V56-0HN3-0 113C-20JM-4 2V51-29H4-H 5U0D-63JK-G 7438-16GM-R 085D-5VMH-8 175C-7UMF-2 1D6D-1JPH-6 2K4U-45K5-U 3C44-7ELE-4 4A6T-5ZH1-1 6W4V-7RPJ-7 273A-13JG-L 2561-74NU-T 6627-6MKH-U 0C1E-7HJU-3 2W3P-51MJ-B 5M2X-65P4-9 2816-1MHK-7 0K25-14LG-Z 460H-6AMX-H 4U2P-6HHJ-T 6D62-19MD-9 2Y2R-05HF-5 4W2V-3VM1-7 5P0P-3TLN-5 6V7B-1XPT-X 754R-5GPU-Y 691X-3CH6-P 024J-7WMK-3 1036-4KHG-N 135C-7UMF-E 4L0Y-2DMM-T 545X-32PN-F 5A4T-57JE-R 623Z-2RHR-9 730U-08NR-4 4X2K-2TP9-Z 692U-1BLC-X 7G6G-7PGV-W 4R2V-3VM1-K 591J-18LJ-G 1K1V-48PE-Z 3Y2E-7YK1-C 6H5F-0ZNF-M 7769-1PJ5-Y 794M-43JR-U 7E4F-1GL2-T 087H-7LPC-6 0N48-4XM7-X 0R1W-2MNL-2 077H-7LPC-9 6L4V-7RPJ-Z 7T4G-0GN9-Z 2M3U-6ZJ1-2 5G6X-3XNY-W 6P76-1HM0-P 1U24-5CKL-9 1W3A-13JG-N 1Z4K-2BNM-D 2213-59N8-R 2M7Z-71KX-H 5L1U-5LH0-4 704D-0EG2-2 0J5L-55J9-2 115M-4LGG-4 2E67-33KR-A 7E17-4CLX-R 455V-11KG-R 0Y2W-7DL9-1 2646-12JD-N 553D-41PZ-B 5A2X-65P4-A 5H21-07LZ-X 687M-2AGC-4 7P4B-40KU-J 2L0L-0FKE-A 573H-5PP3-L 244U-45K5-7 284W-72P0-G 4W7V-7BG9-K 521J-18LJ-5 5F1U-5LH0-K 0P4Y-78J7-V 2M5R-3FHA-B 2X44-7ELE-J 5L2N-0WPA-N 6X64-7XLV-8 084H-1CJJ-A 0M36-4KHG-R 170W-0TLA-3 1879-49M4-P 1E3V-3PJ8-Z 1T4K-2BNM-Z 2D6Z-1ZL8-N 2G7Z-71KX-0 4A66-5XN6-U 4C66-5XN6-L 4F7F-0BLD-V 5D52-30PD-R 5N1L-1TLH-3 5N3Z-2RHR-E 6C4V-7RPJ-P 6N4Z-6KKD-E 7A3T-6YM2-U 1H7N-5FNJ-T 4W2Z-3RLW-L 061T-7TJA-R 756G-7PGV-X 0Z7Y-76MW-6 1015-5DJ6-B 264N-2LKY-K 2P12-0MNA-H 5A5Z-2KH5-G 2Z1G-5NMA-C 332B-5YJP-B 3B7R-5KGZ-L 4V4T-57JE-6 6P3W-3UN7-A 121R-22HW-3 2C0L-0FKE-2 2T2H-6LPP-J 317W-00G0-7 523N-67ME-8 6L0U-08NR-J 767A-4EJH-H 687B-1XPT-N 6T69-1PJ5-9 0F4Y-78J7-K 4U39-3JGK-2 1Y2E-0NNG-X 5G2W-1VNP-A 450L-23HD-U 3Z4R-2LKY-9 161B-6NGR-P 266K-7PGV-J 1J3M-6VGP-Z 6C5J-0ZNF-P 3C4H-34MB-X 1966-5EHN-8 0T7U-56K0-R 176A-7VM6-7 3G2V-05HF-1 6Y79-1HM0-M 7U4C-44NB-E 4V6C-1PJ5-R 351H-01JC-K 453C-3JGK-L 375F-7UMF-K 7A3M-6VGP-H 0V6D-2ZKV-V 7M4J-1GL2-P 7G5U-5HMV-N 0V4G-0EG2-B 3J0H-60JV-5 4348-54M3-0 5G16-59N8-Y 0E5X-2PJT-N 7250-5JHY-Y 6U4M-7WMK-8 3Y4W-57JE-H 713Z-3UN7-Y 2630-65P4-3 5C5L-0JLM-F 1X5Z-2VNH-U 5420-1WJ2-2 4E2D-6DHP-N 190Y-6FKB-V 7858-68PX-U 6E3G-0KN0-G 663N-28MC-C 6G6X-52P8-H 0Z3R-67ME-R 5R3Y-3PJ8-G 325N-73HZ-G 6U22-0XNW-9 2G6W-5ZH1-4 632A-2WG5-N 5531-3RLW-H 1W0U-3TLN-D 6J2L-6LPP-N 2W2B-2WG5-0 0C4Y-7RPJ-G 1P22-0XNW-P 213L-5PP3-W 4U06-4ZPR-6 173D-13JG-8 7741-0LJ3-L 1B1J-01JC-L 0802-71KX-C 067T-5FNJ-E 5K2N-1RHT-X 7C08-4RG3-J 1K7G-2UGW-K 0B5K-10GT-X 2645-5RM5-8 0V5M-73HZ-P 3N03-1FHE-1 4P1N-25G7-U 737K-7LPC-G 7614-0MNA-1 7722-0XNW-1 2V6P-3KLU-G 7N05-5TLL-8 0C0F-69LP-X 2N1Z-3CH6-N 3813-4GJY-B 0214-0MNA-L 0D5N-55J9-K 1966-7XLV-B 3745-77KZ-3 3K2L-47P7-X 151K-5NMA-E 3M7K-7CNC-Z 617X-31N5-0 2N3V-6YM2-X 5A7E-1XPT-4 2F7X-31N5-U 552R-79HL-3 016X-52P8-4 7H5W-2PJT-M 6419-2JPY-T 622Z-7NPM-Y 730B-02P6-L 4Z26-14LG-8 3830-3RLW-T 7X3Y-7ZPB-P 6R5M-55J9-V 720K-6GLT-B 603J-5PP3-T
  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.

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

Recall Details

Company:
Philips North America
Reason for Recall:
During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Product Codes/Lot Numbers:

UDI-DI: 00884838104594; Serial Numbers:0Y5Z-7FHX-N 5H20-1DNN-E 1762-74NU-5 1C0V-08NR-0 6U53-30PD-1 6M5J-0JLM-H 2M2G-15LB-E 4U3A-3JGK-K 0439-16GM-G 3A1T-22HW-U 534U-57JE-Y 0D6U-5ZH1-D 3H5C-6JK9-X 3K0C-3EH3-H 3Z47-12JD-V 524N-43JR-2 5N40-2RHR-N 1331-5BNT-B 1V4F-34MB-G 1B4R-37N1-3 6D3L-28MC-M 7Y52-29H4-L 7Y5Z-7FHX-F 1X6W-21KC-W 6278-09GU-Y 2C6N-3KLU-C 3E5Y-32PN-4 5T2L-2TP9-V 021Z-1WJ2-5 1W6W-21KC-Z 7L3H-46MR-L 194D-2YHB-T 1Y7A-49M4-6 2Z3C-1AHM-3 4T51-53NK-A 1P4A-44NB-V 3B5M-55J9-5 5V57-0HN3-J 7V5Z-7FHX-R 224B-2HJF-F 5G1G-01JC-Z 6Y7F-06MT-0 676T-6XMZ-M 5F1G-01JC-2 5K2B-6DHP-4 5T45-7ELE-C 0V7B-4EJH-A 1F23-36KM-0 2C50-6KKD-R 3107-4RG3-6 3X5B-1NH8-2 6U32-24GX-0 5K2L-2TP9-D 4T2R-6HHJ-D 613L-28MC-T 7K21-0XNW-C 062U-1VNP-B 5M78-09GU-6 6226-14LG-X 0V6R-0PLF-7 5K72-2NL7-J 7G21-0XNW-M 077M-7JG6-L 2R4Y-5JHY-8 7Z4E-0EG2-N 1X2J-6LPP-R 1Y0A-64MU-A 0Z3E-41PZ-K 327Y-2CJW-6 3979-6CPV-0 2150-6KKD-T 4E6Z-70HU-B 1H3G-4UJL-D 2A75-27LY-3 3X3J-5PP3-5 4V7G-0BLD-8 567W-7BG9-5 5K6K-0RGF-L 6F2V-1BLC-W 0106-0UH7-D 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2F7X-31N5-U 552R-79HL-3 016X-52P8-4 7H5W-2PJT-M 6419-2JPY-T 622Z-7NPM-Y 730B-02P6-L 4Z26-14LG-8 3830-3RLW-T 7X3Y-7ZPB-P 6R5M-55J9-V 720K-6GLT-B 603J-5PP3-T

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0035-2025

Related Recalls

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Apr 14, 2026 Other Medical Devices Nationwide View Details β†’

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Apr 14, 2026 Other Medical Devices Nationwide View Details β†’