FDA recall, , Moderate risk
Philips Azurion Systems
Philips Azurion Systems R3.0 have software issues that may cause loss of X-ray and other problems.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V., based in Best, Netherlands, recalled 990 units of its Philips Azurion Systems R3.0 nationwide and worldwide due to nine identified software issues.
These issues may result in 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, and longitudinal position error.
The recall began on December 8, 2025, and was added to the FDA's Enforcement Report on January 14, 2026.
The affected products include label descriptions and corresponding models such as Azurion 3 M12 (Model Number 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). The distribution covers the US nationwide and numerous countries worldwide. The recall was classified by the FDA on January 14, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12.
- Model
- 722229
- UDI-DI
- 00884838116726
- 00884838116733
- 00884838116740
- 00884838116757
- 00884838116788
- 00884838116801
- 00884838116764
- 00884838116771
Recall details
- Company began the recall
- Sold in
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, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98071
- Recall number
- Z-1079-2026
- Quantity recalled
- 990 units
All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
