Recall Z-2170-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
| Date | May 12, 2026 (initiated Mar 31, 2026) |
| Status | Open, Classified |
| Reason | Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. |
| Root cause | Device Design |
| Action | Philips notified consignees on about 03/31/2026 via "URGENT Medical Device Correction" letter. Consignees were instructed to circulate the letter to all users of the system so that they are aware of the issue and follow the instructions, maintain the notification with the documentation of the system until Philips corrects the system, and notify consignees/facilities in case the affected system has been transferred. Consignees were also requested to complete and return the provided response form to Philips. Philips is starting installation of the redesigned Cable Hose Carrier assembly on the a |
| Quantity | 1,718 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |