Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Softw
Pending LLM rewrite. Source: FDA_DEVICE Z-1345-2026.
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 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); 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 (9)
- System Model Numbers: (1) 722064
- (2) 722222
- (3) 722230
- (4)722280(OUS only)
- UDI-DIs: (1) 884838085282
- (2) 884838099210
- (3) 884838116733
- (4)N/A
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
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