FDA recall, , Moderate risk
Philips Azurion
Philips Azurion x-ray system has software issues that may delay therapy and cause procedural complications.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V., located in Best, Netherlands, recalled its Philips Azurion interventional fluoroscopic x-ray system, models 722229 through 722236, with software versions R3.0 and R3.1. The recall began July 16, 2026, and the FDA added it to its Enforcement Report on August 10, 2026.
Two software related issues affect the systems: potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment, and potential loss of geometry movements that may lead to delay of therapy and procedural complications. Distribution is worldwide.
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?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Azurion
- Model number
- 722229
- 722230
- 722231
- 722232
- 722233
- 722234
- 722235
- 722236
- UDI-DI
- 00884838116757
- 00884838116771
- 00884838116801
- 00884838116733
- 00884838116764
- 00884838116788
- 00884838116740
- 00884838116726
- 0088483811680
Recall details
- Company began the recall
- Sold in
Worldwide distribution.
- 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
- 99423
- Recall number
- Z-2932-2026
- Quantity recalled
- 2016 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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
