Recall Z-2502-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion
| Date | Sep 3, 2025 (initiated Aug 1, 2025) |
| Status | Open, Classified |
| Reason | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. |
| Root cause | Under Investigation by firm |
| Action | Philips notified consignees on about 08/01/2025 via letter. Consignees were informed that systems may still be utilized in accordance with their Instructions for Use (IFU), notify all applicable personnel of this recall, maintain the Urgent Medical Device Correction letter with documentation of the system until Philips corrects the system, and establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. If an affected system has been transferred to another organ |
| Quantity | 1,861 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hun |
| FDA record | Open on fda.gov |