Recall Z-1583-2025 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Medical Systems Nederland B.V.
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
| Date | Apr 21, 2025 (initiated Jul 20, 2023) |
| Status | Open, Classified |
| Reason | Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch. |
| Root cause | Software design |
| Action | Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the following actions that should be taken to prevent risks to patients: Keep the Electronic Product Radiation Correction letter with the documentation of the system. Where possible, place the Wireless Foot Switch within a 3 meter range from the C-arm stand to minimize as much as possible the potential delay of 72 milliseconds. Circulate this Electronic Product Radiation Correction letter to all users of the system so that they are aware of the issue. Philips will c |
| Quantity | 12 systems |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |