Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions:
Pending LLM rewrite. Source: FDA_DEVICE Z-1350-2026.
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
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
The recalled product
- Product
- Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
- 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 (6)
- System Model Numbers: (1)722227
- (2)722231
- UDI-DIs: (1)884838099227
- (2)884838099258
- (3)884838116740
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
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