Recall Z-1674-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
| Date | Mar 27, 2026 (initiated Mar 3, 2026) |
| Status | Open, Classified |
| Reason | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| Root cause | Device Design |
| Action | On March 3, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue and follow the instructions below. 2. Perform the daily check before starting the first procedure, as described in the device labelling 3. Should you experience a foot switch activation issue, please report it to your local Philips representative. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device |
| Quantity | 798 units (42 US, 756 OUS) |
| Distribution | Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.