Philips Azurion Systems R3.0 Software Issues: Risk of Image Loss and System Failures
Philips recalls Azurion Systems R3.0 models (722229-722234) due to 9 software issues that may cause image loss, system restarts, and misalignment. Affected units include Azurion 3 M12 through 7 M20 models with specific UDI numbers.
Lower-risk 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.
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What happened, in plain English
Philips is recalling Azurion Systems R3.0 models (including Azurion 3 M12 through 7 M20) due to nine software issues that could cause image loss, system restarts, and misalignment of medical imaging tools. This affects medical imaging equipment used in hospitals and clinics. Read more at govinfonow.com/recall/50513-philips-azurion-systems-r3-0-software-issues-risk-of-image.
Source Summary by GovInfoNow · govinfonow.com/recall/50513-philips-azurion-systems-r3-0-software-issues-risk-of-image · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1079-2026
Cite this page
“Philips Azurion Systems R3.0 Software Issues: Risk of Image Loss and System Failures.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50513-philips-azurion-systems-r3-0-software-issues-risk-of-image. Based on FDA recall #Z-1079-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1079-2026%22&limit=1).
Why it’s dangerous
Nine software issues may cause image loss after pedal taps or phase faults, missing live X-ray displays on monitors, system restarts, drive failures, and misaligned imaging tools. These problems could lead to inaccurate medical images but do not cause direct injury.
Who’s affected
Medical facilities using Philips Azurion Systems R3.0 models with specific model numbers and UDI codes listed in the recall. Patients and staff at these facilities are at risk if the equipment malfunctions during imaging procedures.
How to tell if you have this one
Check if your Philips Azurion System has a model number between 722229-722234 and UDI numbers listed in the recall. The software version is R3.0 for all affected models.
- Brand
Philips- Product
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12- Category
Medical device
What to do — step by step
Check Your Model
Identify if your Philips Azurion System has a model number between 722229-722234 and UDI numbers listed in the recall.
Contact Philips
Reach out to Philips customer support for assistance with the recall process.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What models are affected by this recall?
Affected models include Azurion 3 M12 (722229), Azurion 3 M15 (722230), Azurion 5 M12 (722231), Azurion 5 M20 (722232), Azurion 7 B12 (722235), Azurion 7 B20 (722236), Azurion 7 M12 (722233), and Azurion 7 M20 (722234).
Do I need to stop using my equipment immediately?
No immediate stop is required, but affected units should be checked against the recall list and contacted with Philips for assistance.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1079-2026 (December 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1079-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.