Recall Z-1091-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion
| Date | Jan 14, 2026 (initiated Dec 12, 2025) |
| Status | Open, Classified |
| Reason | Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error. |
| Root cause | Software design |
| Action | Philips notified consignees on about 12/12/2025 via certified mailing. Consignees were instructed to identify any affected systems on hand, circulate the noification to all users of the system for awareness, notify any recipients if the affected systems have been transferred to another organization, maintain the notification with documentation of the system until Philips completes the correction, and complete and return the response form provided. Philips also provided recommended actions for each issue, if encountered. Philips will address the identified issues by implementing a software upd |
| Quantity | 10,466 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chil |
| FDA record | Open on fda.gov |