Azurion 7 M20. Fluoroscopic X-Ray System.
Pending LLM rewrite. Source: FDA_DEVICE Z-2134-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
The recalled product
- Product
- Azurion 7 M20. Fluoroscopic X-Ray System.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- System Model No. 722079
- UDI: 00884838085268
- Serial No. 525
- 584
- 587
- 613
- 631
- 658
- 708
- 774
- 777
- 793
- 800
- 801
- 838
- 842
- 843
- 862
- 865
- 866
Distribution
Distributed nationwide across the United States.
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