Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Mode
FDA device recall Z-1079-2026 · posted 2026-01-14 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- 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.
- Action taken
- Philips notified consignees on about 12/08/2025 via emailed URGENT Medical Device Correction letter. The letter informed consignees that they have identified nine (9) software issues affecting Azurion R3.0 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. Consignees were instructed to identify all affected units on hand, ensure all users of the affected units are aware of the issue and notify any customers if the unit has been transferred or distributed. Consignees were also instructed to keep the notification with documentation of the system until the issue is resolved, and complete and return the response form. If any of the nine issues are encountered, consignees were asked to contact their local Philips representative and the letter provided recommended actions. ***Updated May 8, 2026*** Previously, Philips planned to address issues 1-7 in software update 3.1.5, while issues 8 and 9 would be addressed separately. Update 3.1.5 has been canceled. Issues 1-9 will now be addressed through software release 3/1/15. Anticipated release date for software version 3.1.15 is Q3 2026. Local Philips representatives will contact each consignee to schedule visits to install the software updates once available.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 990 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia,
- Date initiated
- 2025-12-08
- Date posted
- 2026-01-14
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |