Recall Z-0288-2027 ยท IZL System, X-Ray, Mobile
Philips North America
Model Number: 712010.
| Date | Oct 26, 2026 (initiated Sep 18, 2026) |
| Status | Open, Classified |
| Reason | Potential for the device to fail immediately after an exposure, causing the system to remain stationary. |
| 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 a |
| Quantity | 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, Roman |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233678 | Radiography 7000 M Philips Medical Systems Dmc GmbH, Feb 14, 2024 |