PHILIPS 722227 - 3D Ultrasound Scanner
PHILIPS 722227 3D Ultrasound Scanner - High-resolution imaging for medical diagnostics
Lower-risk recall
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
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What happened, in plain English
PHILIPS 722227 3D Ultrasound Scanner - High-resolution imaging for medical diagnostics Read more at govinfonow.com/recall/50476-philips-722227-3d-ultrasound-scanner.
Source Summary by GovInfoNow · govinfonow.com/recall/50476-philips-722227-3d-ultrasound-scanner · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1091-2026
Cite this page
“PHILIPS 722227 - 3D Ultrasound Scanner.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50476-philips-722227-3d-ultrasound-scanner. Based on FDA recall #Z-1091-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1091-2026%22&limit=1).
Why it’s dangerous
This model is not inherently dangerous but may have specific usage considerations for medical imaging applications.
Who’s affected
All users of the 722227 model
How to tell if you have this one
Check for software updates and ensure proper calibration for accurate imaging results.
- Brand
PHILIPS- Product
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and- Category
Medical device
What to do — step by step
default
Ensure the device is used by trained medical professionals for diagnostic purposes only.
Software update
Regularly check for and install software updates to maintain optimal performance and safety.
calibration
Verify the device's calibration is up to date to ensure accurate imaging results.
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 Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei…” 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 40 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
Is the 722227 model safe for medical use?
Yes, the 722227 model is designed for medical use and meets safety standards when operated correctly.
How often should I update the software?
It is recommended to check for software updates at least once every 6 months to ensure optimal performance and safety.
What should I do if the device shows inaccurate imaging results?
Contact the manufacturer for calibration checks or professional maintenance.
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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-1091-2026 (December 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1091-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.