Recall Z-0294-2027 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5 M12. Model Number: 722227.
| Date | Oct 27, 2026 (initiated Oct 6, 2026) |
| Status | Open, Classified |
| Reason | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images. |
| Root cause | Equipment maintenance |
| Action | Philips Medical notified consignees on about 10/06/2026 via certified mailed letter titled "URGENT Medical Device Correction." Consignees were instructed that affected systems may continue to be used in accordance with their Instructions for Use (IFU) and the additional instructions provided, which include: if motorized movements become unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2), and rotational (3) stand movements remain available. Note: Tra |
| Quantity | 60 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 Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, |
| FDA record | Open on fda.gov |