[pending] Philips Azurion system; Software Version Number: R3.1;
Pending LLM rewrite. Source: FDA_DEVICE Z-1113-2026.
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
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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