Z-0288-2027
Model Number: 712010
Philips North America / initiated 2026-09-18 / Open, Classified
Recall record
- Recall number
- Z-0288-2027
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America
- Product
- Model Number: 712010.
- Product code
- IZL System, X-Ray, Mobile
- Reason for recall
- Potential for the device to fail immediately after an exposure, causing the system to remain stationary.
- FDA root cause
- Software design
- Action
- Philips Medical Systems notified consignees on about 09/18/2026 via "URGENT Medical Device Correction" letter. Consignees were instructed that they may continue to use the affected system in accordance with its intended use, however if the no-drive issue occurs and prevents repositioning of the system, system movement may be restored through one or more of the following options: - Option 1: System reboot: Power OFF the unit, wait at least 10 seconds, and then power system ON While system startup may take up to 4 minutes, drive functionality will be available within approximately 8 seconds after the unit is powered on. Confirm that drive functionality has been restored before continuing clinical use. - Option 2: Use alternate registered RFID card: Use a different registered RFID card than the one most recently used to log into the system (for example, the backup RFID card kept with the system). Hold the RFID card over the RFID reader until an audible beep is heard (typically within 1 to 3 seconds). Confirm that drive functionality has been restored before continuing clinical use. - Option 3: Manually unlock the wheels using tools provided on the system to free the movement of the system. Consignees were requested to circulate the notification all users of the device for their awareness, retain the notification with the system until the correction is complete and complete and return the provided response form. Philips will be implementing a software correction to address the issue. A Philips representative will contact consignees to schedule implementation when the correction becomes available. If you have any questions, contact the Customer Care Solution Center at 800-722-9377.
- Quantity in commerce
- 563 units
- Distribution
- Worldwide Distribution: (US Nationwide) and International distribution to Angola, Australia, Austria, Canada, Chile, Cook Islands, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Honduras, Israel, Italy, Latvia, Lithuania, Macedonia, Namibia, Netherlands, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Product codes and lots
- Model Number: 712010. UDI: (01)00884838115521(21)26000155, (01)00884838115521(21)26000154, (01)00884838115521(21)26000151, (01)00884838115521(21)26000150, (01)00884838115521(21)26000149, (01)00884838115521(21)26000148, (01)00884838115521(21)26000147, (01)00884838115521(21)26000146, (01)00884838115521(21)26000145, (01)00884838115521(21)26000144, (01)00884838115521(21)26000143, (01)00884838115521(21)26000142, (01)00884838115521(21)26000141, (01)00884838115521(21)26000140, (01)00884838115521(21)26000139, (01)00884838115521(21)26000138, (01)00884838115521(21)26000137, (01)00884838115521(21)26000136, (01)00884838115521(21)26000135, (01)00884838115521(21)26000134, (01)00884838115521(21)26000133, (01)00884838115521(21)26000132, (01)00884838115521(21)26000129, (01)00884838115521(21)26000125, (01)00884838115521(21)26000126, (01)00884838115521(21)26000131, (01)00884838115521(21)26000130, (01)00884838115521(21)26000124, (01)00884838115521(21)26000123, (01)00884838115521(21)26000122, (01)00884838115521(21)26000121, (01)00884838115521(21)26000120, (01)00884838115521(21)26000119, (01)00884838115521(21)26000118, (01)00884838115521(21)26000116, (01)00884838115521(21)26000115, (01)00884838115521(21)26000113, (01)00884838115521(21)26000110, (01)00884838115521(21)26000109, (01)00884838115521(21)26000108, (01)00884838115521(21)26000107, (01)00884838115521(21)26000106, (01)00884838115521(21)26000117, (01)00884838115521(21)26000114, (01)00884838115521(21)26000111, (01)00884838115521(21)26000112, (01)00884838115521(21)26000105, (01)00884838115521(21)26000104, (01)00884838115521(21)26000103, (01)00884838115521(21)26000102, (01)00884838115521(21)26000090, (01)00884838115521(21)26000089, (01)00884838115521(21)26000088, (01)00884838115521(21)26000087, (01)00884838115521(21)26000086, (01)00884838115521(21)26000085, (01)00884838115521(21)26000084, (01)00884838115521(21)26000101, (01)00884838115521(21)26000095, (01)00884838115521(21)26000094, (01)00884838115521(21)26000093, (01)00884838115521(21)26000092, (01)00884838115521(21)26000100, (01)00884838115521(21)26000099, (01)00884838115521(21)26000098, (01)00884838115521(21)26000097, (01)00884838115521(21)26000096, (01)00884838115521(21)26000091, (01)00884838115521(21)26000080, (01)00884838115521(21)26000079, (01)00884838115521(21)26000083, (01)00884838115521(21)26000082, (01)00884838115521(21)26000081, (01)00884838115521(21)26000078, (01)00884838115521(21)26000076, (01)00884838115521(21)26000073, (01)00884838115521(21)26000070, (01)00884838115521(21)26000067, (01)00884838115521(21)26000048, (01)00884838115521(21)26000047, (01)00884838115521(21)26000046, (01)00884838115521(21)26000045, (01)00884838115521(21)26000074, (01)00884838115521(21)26000058, (01)00884838115521(21)26000057, (01)00884838115521(21)26000056, (01)00884838115521(21)26000055, (01)00884838115521(21)26000044, (01)00884838115521(21)26000043, (01)00884838115521(21)26000041, (01)00884838115521(21)26000040, (01)00884838115521(21)26000072, (01)00884838115521(21)26000071, (01)00884838115521(21)26000075, (01)00884838115521(21)26000065, (01)00884838115521(21)26000064, (01)00884838115521(21)26000068, (01)00884838115521(21)26000063, (01)00884838115521(21)26000006, (01)00884838115521(21)26000005, (01)00884838115521(21)26000004, (01)00884838115521(21)26000003, (01)00884838115521(21)26000002, (01)00884838115521(21)26000001, (01)00884838115521(21)26000042, (01)00884838115521(21)26000062, (01)00884838115521(21)26000061, (01)00884838115521(21)26000060, (01)00884838115521(21)26000059, (01)00884838115521(21)26000037, (01)00884838115521(21)26000054, (01)00884838115521(21)26000053, (01)00884838115521(21)26000052, (01)00884838115521(21)26000051, (01)00884838115521(21)26000050, (01)00884838115521(21)26000049, (01)00884838115521(21)26000038, (01)00884838115521(21)26000036, (01)00884838115521(21)26000035, (01)00884838115521(21)26000034, (01)00884838115521(21)26000032, (01)00884838115521(21)26000029, (01)00884838115521(21)26000028, (01)00884838115521(21)26000033, (01)00884838115521(21)26000031, (01)00884838115521(21)26000027, (01)00884838115521(21)26000026, (01)00884838115521(21)26000025, (01)00884838115521(21)26000020, (01)00884838115521(21)26000024, (01)00884838115521(21)26000023, (01)00884838115521(21)26000022, (01)00884838115521(21)26000021, (01)00884838115521(21)26000018, (01)00884838115521(21)26000019, (01)00884838115521(21)26000017, (01)00884838115521(21)26000016, (01)00884838115521(21)26000015, (01)00884838115521(21)26000014, (01)00884838115521(21)26000013, (01)00884838115521(21)26000012, (01)00884838115521(21)26000009, (01)00884838115521(21)26000008, (01)00884838115521(21)26000007, (01)00884838115521(21)26000011, (01)00884838115521(21)26000010, (01)00884838115521(21)25000233, (01)00884838115521(21)25000232, (01)00884838115521(21)25000234, (01)00884838115521(21)25000231, (01)00884838115521(21)25000230, (01)00884838115521(21)25000229, (01)00884838115521(21)25000223, (01)00884838115521(21)25000216, (01)00884838115521(21)25000228, (01)00884838115521(21)25000227, (01)00884838115521(21)25000222, (01)00884838115521(21)25000221, (01)00884838115521(21)25000226, (01)00884838115521(21)25000225, (01)00884838115521(21)25000224, (01)00884838115521(21)25000220, (01)00884838115521(21)25000219, (01)00884838115521(21)25000215, (01)00884838115521(21)25000213, (01)00884838115521(21)25000218, (01)00884838115521(21)25000217, (01)00884838115521(21)25000214, (01)00884838115521(21)25000210, (01)00884838115521(21)25000209, (01)00884838115521(21)25000212, (01)00884838115521(21)25000211, (01)00884838115521(21)25000208, (01)00884838115521(21)25000205, (01)00884838115521(21)25000206, (01)00884838115521(21)25000204, (01)00884838115521(21)25000207, (01)00884838115521(21)25000203, (01)00884838115521(21)25000202, (01)00884838115521(21)25000201, (01)00884838115521(21)25000200, (01)00884838115521(21)25000197, (01)00884838115521(21)25000199, (01)00884838115521(21)25000198, (01)00884838115521(21)25000187, (01)00884838115521(21)25000186, (01)00884838115521(21)25000195, (01)00884838115521(21)25000194, (01)00884838115521(21)25000193, (01)00884838115521(21)25000192, (01)00884838115521(21)25000191, (01)00884838115521(21)25000190, (01)00884838115521(21)25000189, (01)00884838115521(21)25000181, (01)00884838115521(21)25000188, (01)00884838115521(21)25000185, (01)00884838115521(21)25000184, (01)00884838115521(21)25000182, (01)00884838115521(21)25000180, (01)00884838115521(21)25000183, (01)00884838115521(21)25000174, (01)00884838115521(21)25000179, (01)00884838115521(21)25000176, (01)00884838115521(21)25000168, (01)00884838115521(21)25000178, (01)00884838115521(21)25000177, (01)00884838115521(21)25000175, (01)00884838115521(21)25000166, (01)00884838115521(21)25000173, (01)00884838115521(21)25000172, (01)00884838115521(21)25000171, (01)00884838115521(21)25000169, (01)00884838115521(21)25000167, (01)00884838115521(21)25000170, (01)00884838115521(21)25000165, (01)00884838115521(21)25000164, (01)00884838115521(21)25000163, (01)00884838115521(21)25000162, (01)00884838115521(21)25000160, (01)00884838115521(21)25000159, (01)00884838115521(21)25000158, (01)00884838115521(21)25000157, (01)00884838115521(21)25000156, (01)00884838115521(21)25000155, (01)00884838115521(21)25000161, (01)00884838115521(21)25000154, (01)00884838115521(21)25000153, (01)00884838115521(21)25000152, (01)00884838115521(21)25000151, (01)00884838115521(21)25000146, (01)00884838115521(21)25000150, (01)00884838115521(21)25000148, (01)00884838115521(21)25000149, (01)00884838115521(21)25000147, (01)00884838115521(21)25000145, (01)00884838115521(21)25000142, (01)00884838115521(21)25000121, (01)00884838115521(21)25000141, (01)00884838115521(21)25000144, (01)00884838115521(21)25000143, (01)00884838115521(21)25000140, (01)00884838115521(21)25000139, (01)00884838115521(21)25000133, (01)00884838115521(21)25000135, (01)00884838115521(21)25000134, (01)00884838115521(21)25000130, (01)00884838115521(21)25000138, (01)00884838115521(21)25000132, (01)00884838115521(21)25000137, (01)00884838115521(21)25000126, (01)00884838115521(21)25000136, (01)00884838115521(21)25000131, (01)00884838115521(21)25000120, (01)00884838115521(21)25000128, (01)00884838115521(21)25000127, (01)00884838115521(21)25000129, (01)00884838115521(21)25000125, (01)00884838115521(21)25000124, (01)00884838115521(21)25000122, (01)00884838115521(21)25000123, (01)00884838115521(21)25000119, (01)00884838115521(21)25000115, (01)00884838115521(21)25000114, (01)00884838115521(21)25000118, (01)00884838115521(21)25000112, (01)00884838115521(21)25000110, (01)00884838115521(21)25000116, (01)00884838115521(21)25000113, (01)00884838115521(21)25000109, (01)00884838115521(21)25000107, (01)00884838115521(21)25000106, (01)00884838115521(21)25000105, (01)00884838115521(21)25000104, (01)00884838115521(21)25000103, (01)00884838115521(21)25000102, (01)00884838115521(21)25000101, (01)00884838115521(21)25000117, (01)00884838115521(21)25000100, (01)00884838115521(21)25000099, (01)00884838115521(21)25000098, (01)00884838115521(21)25000097, (01)00884838115521(21)25000096, (01)00884838115521(21)25000095, (01)00884838115521(21)25000111, (01)00884838115521(21)25000108, (01)00884838115521(21)25000077, (01)00884838115521(21)25000094, (01)00884838115521(21)25000093, (01)00884838115521(21)25000092, (01)00884838115521(21)25000091, (01)00884838115521(21)25000090, (01)00884838115521(21)25000089, (01)00884838115521(21)25000088, (01)00884838115521(21)25000087, (01)00884838115521(21)25000084, (01)00884838115521(21)25000083, (01)00884838115521(21)25000082, (01)00884838115521(21)25000086, (01)00884838115521(21)25000085, (01)00884838115521(21)25000081, (01)00884838115521(21)25000080, (01)00884838115521(21)25000079, (01)00884838115521(21)25000078, (01)00884838115521(21)25000076, (01)00884838115521(21)25000075, (01)00884838115521(21)25000074, (01)00884838115521(21)25000073, (01)00884838115521(21)25000072, (01)00884838115521(21)25000071, (01)00884838115521(21)25000068, (01)00884838115521(21)25000067, (01)00884838115521(21)25000066, (01)00884838115521(21)25000061, (01)00884838115521(21)25000070, (01)00884838115521(21)25000069, (01)00884838115521(21)25000065, (01)00884838115521(21)25000064, (01)00884838115521(21)25000063, (01)00884838115521(21)25000062, (01)00884838115521(21)25000060, (01)00884838115521(21)25000058, (01)00884838115521(21)25000057, (01)00884838115521(21)25000050, (01)00884838115521(21)25000056, (01)00884838115521(21)25000055, (01)00884838115521(21)25000054, (01)00884838115521(21)25000053, (01)00884838115521(21)25000052, (01)00884838115521(21)25000051, (01)00884838115521(21)25000044, (01)00884838115521(21)25000059, (01)00884838115521(21)25000022, (01)00884838115521(21)25000049, (01)00884838115521(21)25000048, (01)00884838115521(21)25000047, (01)00884838115521(21)25000045, (01)00884838115521(21)25000046, (01)00884838115521(21)25000042, (01)00884838115521(21)25000038, (01)00884838115521(21)25000043, (01)00884838115521(21)25000041, (01)00884838115521(21)25000040, (01)00884838115521(21)25000039, (01)00884838115521(21)25000033, (01)00884838115521(21)25000031, (01)00884838115521(21)25000030, (01)00884838115521(21)25000009, (01)00884838115521(21)25000037, (01)00884838115521(21)25000036, (01)00884838115521(21)25000035, (01)00884838115521(21)25000034, (01)00884838115521(21)25000032, (01)00884838115521(21)25000018, (01)00884838115521(21)25000020, (01)00884838115521(21)25000028, (01)00884838115521(21)25000027, (01)00884838115521(21)25000016, (01)00884838115521(21)25000023, (01)00884838115521(21)25000005, (01)00884838115521(21)25000029, (01)00884838115521(21)25000026, (01)00884838115521(21)25000025, (01)00884838115521(21)25000024, (01)00884838115521(21)25000019, (01)00884838115521(21)25000017, (01)00884838115521(21)25000012, (01)00884838115521(21)25000006, (01)00884838115521(21)25000002, (01)00884838115521(21)25000015, (01)00884838115521(21)25000014, (01)00884838115521(21)24000209, (01)00884838115521(21)25000021, (01)00884838115521(21)25000013, (01)00884838115521(21)25000011, (01)00884838115521(21)25000003, (01)00884838115521(21)25000001, (01)00884838115521(21)25000007, (01)00884838115521(21)25000008, (01)00884838115521(21)25000004, (01)00884838115521(21)25000010, (01)00884838115521(21)24000198, (01)00884838115521(21)24000202, (01)00884838115521(21)24000199, (01)00884838115521(21)24000211, (01)00884838115521(21)24000210, (01)00884838115521(21)24000203, (01)00884838115521(21)24000208, (01)00884838115521(21)24000206, (01)00884838115521(21)24000205, (01)00884838115521(21)24000204, (01)00884838115521(21)24000197, (01)00884838115521(21)24000179, (01)00884838115521(21)24000178, (01)00884838115521(21)24000177, (01)00884838115521(21)24000213, (01)00884838115521(21)24000188, (01)00884838115521(21)24000187, (01)00884838115521(21)24000185, (01)00884838115521(21)24000212, (01)00884838115521(21)24000194, (01)00884838115521(21)24000193, (01)00884838115521(21)24000191, (01)00884838115521(21)24000190, (01)00884838115521(21)24000172, (01)00884838115521(21)24000171, (01)00884838115521(21)24000169, (01)00884838115521(21)24000192, (01)00884838115521(21)24000180, (01)00884838115521(21)24000174, (01)00884838115521(21)24000173, (01)00884838115521(21)24000170, (01)00884838115521(21)24000183, (01)00884838115521(21)24000182, (01)00884838115521(21)24000184, (01)00884838115521(21)24000195, (01)00884838115521(21)24000175, (01)00884838115521(21)24000189, (01)00884838115521(21)24000181, (01)00884838115521(21)24000163, (01)00884838115521(21)24000167, (01)00884838115521(21)24000162, (01)00884838115521(21)24000161, (01)00884838115521(21)24000160, (01)00884838115521(21)24000166, (01)00884838115521(21)24000176, (01)00884838115521(21)24000164, (01)00884838115521(21)24000158, (01)00884838115521(21)24000155, (01)00884838115521(21)24000157, (01)00884838115521(21)24000118, (01)00884838115521(21)24000168, (01)00884838115521(21)24000165, (01)00884838115521(21)24000154, (01)00884838115521(21)24000153, (01)00884838115521(21)24000152, (01)00884838115521(21)24000151, (01)00884838115521(21)24000156, (01)00884838115521(21)24000144, (01)00884838115521(21)24000138, (01)00884838115521(21)24000149, (01)00884838115521(21)24000148, (01)00884838115521(21)24000146, (01)00884838115521(21)24000145, (01)00884838115521(21)24000142, (01)00884838115521(21)24000126, (01)00884838115521(21)24000125, (01)00884838115521(21)24000150, (01)00884838115521(21)24000147, (01)00884838115521(21)24000143, (01)00884838115521(21)24000141, (01)00884838115521(21)24000140, (01)00884838115521(21)24000139, (01)00884838115521(21)24000137, (01)00884838115521(21)24000133, (01)00884838115521(21)24000131, (01)00884838115521(21)24000130, (01)00884838115521(21)24000123, (01)00884838115521(21)24000107, (01)00884838115521(21)24000119, (01)00884838115521(21)24000129, (01)00884838115521(21)24000122, (01)00884838115521(21)24000117, (01)00884838115521(21)24000115, (01)00884838115521(21)24000114, (01)00884838115521(21)24000112, (01)00884838115521(21)24000111, (01)00884838115521(21)24000110, (01)00884838115521(21)24000086, (01)00884838115521(21)24000116, (01)00884838115521(21)24000109, (01)00884838115521(21)24000090, (01)00884838115521(21)24000108, (01)00884838115521(21)24000104, (01)00884838115521(21)24000097, (01)00884838115521(21)24000105, (01)00884838115521(21)24000106, (01)00884838115521(21)24000102, (01)00884838115521(21)24000101, (01)00884838115521(21)24000100, (01)00884838115521(21)24000099, (01)00884838115521(21)24000089, (01)00884838115521(21)24000087, (01)00884838115521(21)24000103, (01)00884838115521(21)24000098, (01)00884838115521(21)24000085, (01)00884838115521(21)24000088, (01)00884838115521(21)24000080, (01)00884838115521(21)24000079, (01)00884838115521(21)24000078, (01)00884838115521(21)24000077, (01)00884838115521(21)24000096, (01)00884838115521(21)24000095, (01)00884838115521(21)24000094, (01)00884838115521(21)24000084, (01)00884838115521(21)24000093, (01)00884838115521(21)24000092, (01)00884838115521(21)24000091, (01)00884838115521(21)24000083, (01)00884838115521(21)24000082, (01)00884838115521(21)24000081, (01)00884838115521(21)24000069, (01)00884838115521(21)24000076, (01)00884838115521(21)24000075, (01)00884838115521(21)24000074, (01)00884838115521(21)24000072, (01)00884838115521(21)24000073, (01)00884838115521(21)24000071, (01)00884838115521(21)24000065, (01)00884838115521(21)24000057, (01)00884838115521(21)24000068, (01)00884838115521(21)24000067, (01)00884838115521(21)24000064, (01)00884838115521(21)24000063, (01)00884838115521(21)24000062, (01)00884838115521(21)24000061, (01)00884838115521(21)24000060, (01)00884838115521(21)24000059, (01)00884838115521(21)24000053, (01)00884838115521(21)24000058, (01)00884838115521(21)24000052, (01)00884838115521(21)24000066, (01)00884838115521(21)24000055, (01)00884838115521(21)24000054, (01)00884838115521(21)24000051, (01)00884838115521(21)24000049, (01)00884838115521(21)24000056, (01)00884838115521(21)24000034, (01)00884838115521(21)24000035, (01)00884838115521(21)24000050, (01)00884838115521(21)24000033, (01)00884838115521(21)24000048, (01)00884838115521(21)24000044, (01)00884838115521(21)24000041, (01)00884838115521(21)24000040, (01)00884838115521(21)24000043, (01)00884838115521(21)24000042, (01)00884838115521(21)24000036, (01)00884838115521(21)24000032, (01)00884838115521(21)24000031, (01)00884838115521(21)24000030, (01)00884838115521(21)24000038, (01)00884838115521(21)24000037, (01)00884838115521(21)24000047, (01)00884838115521(21)24000046, (01)00884838115521(21)24000045, (01)00884838115521(21)24000039, (01)00884838115521(21)24000028, (01)00884838115521(21)24000025, (01)00884838115521(21)24000027, (01)00884838115521(21)24000026, (01)00884838115521(21)24000020, (01)00884838115521(21)24000029, (01)00884838115521(21)24000014, (01)00884838115521(21)24000024, (01)00884838115521(21)24000023, (01)00884838115521(21)24000022, (01)00884838115521(21)24000021, (01)00884838115521(21)24000019, (01)00884838115521(21)24000018, (01)00884838115521(21)24000015, (01)00884838115521(21)24000013, (01)00884838115521(21)24000017, (01)00884838115521(21)24000016.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.