Recall Z-2134-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20. Fluoroscopic X-Ray System.
| Date | Jul 18, 2025 (initiated Jun 4, 2025) |
| Status | Open, Classified |
| Reason | Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. |
| Root cause | Device Design |
| Action | A "Device URGENT Medical Device Correction" notification dated 6/03/2025 was mailed to consignees. Consignees are instructed to circulate the provided notification to all system users and keep a copy of the recall notification with affected devices to maintain awareness. If you notice unusual noise during C-arm roll motion, or if the C-arm roll motion is disabled and the user message Motorized movement is not available appears, immediately contact a Philips representative. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your syst |
| Quantity | 78 units |
| Distribution | Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL, IN, KY, MA, MD, MN, MO, MT, NJ, NV, NY, OH, SC, TX, WA; and OUS (Foreign) to countries of: Argentina (AR), Australia (AU), Canada (CA), Chile (CL), Germany (DE), Dominican Republic (DO), Egypt (EG), ES, France (FR), United |
| FDA record | Open on fda.gov |