Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Pending LLM rewrite. Source: FDA_DEVICE Z-1680-2026.
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
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
The recalled product
- Product
- Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
- 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)
- (1) System Code: 722228
- UDI: 00884838099234
- System Serial Number: 67
- 524
- 49
- 678
- 679
- 10
- 36
- 64
- 110
- 403
- 328
- 481
- 373
- 149
- 213
- 45
- 537
- 615
Distribution
Distributed nationwide across the United States.
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