Recall Z-2403-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Medical Systems Nederland B.V.
Azurion
| Date | Sep 7, 2023 (initiated Jul 19, 2023) |
| Status | Open, Classified |
| Reason | A 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 | Radiation Control for Health and Safety Act |
| Action | Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user 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 reference 2023-IGT-BST-011). |
| Quantity | 5432 systems in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |