Recall Z-1581-2025 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America Llc
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
| Date | Apr 21, 2025 (initiated Feb 25, 2025) |
| Status | Open, Classified |
| Reason | A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. |
| Root cause | Labeling 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 actions that should be taken in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. Philips proposes sending the Electronic Product Radiation Defect notification to customers immediately upon FDA approval of the corrective action plan, and completion of the remaining a |
| Distribution | US |
| FDA record | Open on fda.gov |