Azurion 5 M12; System Code: (1)722227, (2)722231;
Pending LLM rewrite. Source: FDA_DEVICE Z-1679-2026.
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 M12; System Code: (1)722227, (2)722231;
- 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: 722227
- UDI: 00884838099227
- System Serial Number: 265
- 135
- 88
- 276
- 264
- 271
- 63
- 238
- 360
- 23
- 127
- 159
- 197
- 149
- 54
- 56
- 230
- 192
Distribution
Distributed nationwide across the United States.
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