Philips Azurion system; Software Version Number: R3.1;
Pending LLM rewrite. Source: FDA_DEVICE Z-1113-2026.
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 two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
The recalled product
- Product
- Philips Azurion system; Software Version Number: R3.1;
- 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)
- Software Version Number: R3.1
- (1) Model Number: 722221
- System Product Name: Azurion 3 M12
- UDI-DI: 00884838099203
- Serial Numbers: (2) Model Number: 722222
- System Product Name: Azurion 3 M15
- UDI-DI: 00884838099210
- Serial Numbers: (3) Model Number: 722223
- System Product Name: Azurion 7 M12
- UDI-DI: 00884838099241
- Serial Numbers: (4) Model Number: 722224
- System Product Name: Azurion 7 M20
- UDI-DI: 00884838099258
- Serial Numbers: (5) Model Number: 722225
- System Product Name: Azurion 7 B12
- UDI-DI: 00884838099265
- Serial Numbers: (6) Model Number: 722226
- System Product Name: Azurion 7 B20
- UDI-DI: 00884838099272
- Serial Numbers: (7) Model Number: 722227
Distribution
Distributed in 9 states:
- AR
- AZ
- CO
- DE
- ID
- IL
- IN
- MA
- MO
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