Recall Z-2225-2026 · OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; M
| Date | May 21, 2026 (initiated Apr 28, 2026) |
| Status | Open, Classified |
| Reason | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. |
| Root cause | Device Design |
| Action | Philips Medical notified consignees on about 04/28/2026 via certified mailed letter titled "URGENT Medical Device Correction." Consignees were made aware of the issue and instructed to circulate the notification to all users of the system for awareness, that affected systems may continue to be used in accordance with their Instructions for Use (IFU), if the required position cannot be achieved using the Float Tabletop control for table movement, use alternative system movements (e.g., stand movement) where clinically feasible to adjust the relative position between the system and the patient, |
| Quantity | 5,537 units |
| Distribution | Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Ira |
| FDA record | Open on fda.gov |