[pending] Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-1351-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(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 (7)
- System Model Numbers: (1)722228
- (2)722232
- (3)722281(OUS only)
- UDI-DIs: (1)884838099234
- (2)884838116757
- (3)N/A
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
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