Recall Z-1969-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;
| Date | Jun 12, 2025 (initiated May 28, 2025) |
| Status | Open, Classified |
| Reason | A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-th |
| Root cause | Software design |
| Action | On May 28, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users - Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. - Avoid rapidly pressing and releasing the footswitch pedals. - In case X-ray functionality is not available following the situations described in this letter, perform a cold system restart of the system, as follows: o On the Review Module, press and hold Power Off . o Release the button when |
| Quantity | 9,707 units (2300 US, 7407 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica |
| FDA record | Open on fda.gov |