Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion… Recall
Issued May 27, 2026 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
In May 2026, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
What you should do
- 1 Stop using Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Health
- Recall date
- May 27, 2026
- Units affected
- Not reported
- Sold at
- Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia
- Recall number
- FDA-Z-2227-2026
- Made in
- Netherlands
- Issuing agency
- FDA
In context
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 17 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.