Philips Azurion 3 M12/M15 and Allura R9 M12/M20: Incorrect DICOM Export Risk
Philips recalls Azurion 3 M12, M15 and Allura R9 M12, M20 models due to potential incorrect DICOM export when using downscale option in QA Basic Measurement tool. This may affect medical imaging accuracy during procedures.
Lower-risk recall
When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination.
Contact the company
What happened, in plain English
Philips is recalling specific medical imaging devices that may incorrectly export measurements to external DICOM systems when using the downscale option. This could lead to inaccurate medical imaging data during procedures, potentially affecting patient care. Read more at govinfonow.com/recall/73136-philips-azurion-3-m12-m15-and-allura-r9-m12-m20.
Source Summary by GovInfoNow · govinfonow.com/recall/73136-philips-azurion-3-m12-m15-and-allura-r9-m12-m20 · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0255-2018
Cite this page
“Philips Azurion 3 M12/M15 and Allura R9 M12/M20: Incorrect DICOM Export Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73136-philips-azurion-3-m12-m15-and-allura-r9-m12-m20. Based on FDA recall #Z-0255-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0255-2018%22&limit=1).
Why it’s dangerous
When using the downscale option with the QA Basic Measurement tool, the system may not correctly export measurements to external DICOM destinations. This could result in inaccurate imaging data being used during medical procedures, potentially affecting treatment decisions.
Who’s affected
Medical professionals using Philips Azurion 3 M12, M15 and Allura R9 M12, M20 models for vascular, cardiac, or neurovascular imaging procedures. Patients undergoing procedures with these devices may be at risk of inaccurate imaging data.
How to tell if you have this one
Check if your device is labeled as Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, or Azurion 7 M20. These models were sold with specific serial numbers: 7220063, 722064, 22065, 722066, 722078, 722079.
- Brand
Philips- Category
Medical device
What to do — step by step
Check Device Model
Identify if your device is one of the recalled models: Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, or Azurion 7 M20.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution.” 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 terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these devices?
No immediate action is required, but you should check if your device is affected and follow the recall instructions if needed.
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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-0255-2018 (August 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0255-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.