Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models:
Pending LLM rewrite. Source: FDA_DEVICE Z-1079-2026.
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
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
The recalled product
- Product
- Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.
- 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)
- (01)00884838116726(21)15
- (01)00884838116726(21)16
- (01)00884838116726(21)6
- (01)00884838116726(21)8
- (01)00884838116726(21)4
- (01)00884838116726(21)24
- (01)00884838116726(21)26
- (01)00884838116726(21)20
- (01)00884838116726(21)25
- (01)00884838116726(21)11
- (01)00884838116726(21)21
- (01)00884838116726(21)13
- (01)00884838116726(21)7
- (01)00884838116726(21)10
- (01)00884838116726(21)2
- (01)00884838116726(21)3
- (01)00884838116733(21)40
- (01)00884838116733(21)9
- (01)00884838116733(21)1
- (01)00884838116733(21)38
Distribution
Distributed nationwide across the United States.
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