FDA recall, , Moderate risk
Philips Azurion Interventional Fluoroscopic X-Ray Systems
Philips Azurion Rystem 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., based in Best, Netherlands, recalled its Philips Azurion Rystem, an Interventional Fluoroscopic X-Ray System, due to two software related issues affecting Azurion R2.2.10 Systems.
These issues include 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. The company began the recall on July 16, 2026, and the FDA added it to its Enforcement Report on August 10, 2026, with distribution 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?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China);
Interventional Fluoroscopic X-Ray System- UDI-DI
- 00884838099258
- 00884838085251
- 00884838099241
- 00884838085268
- 00884838099272
- 00884838085367
- 00884838099265
- 00884838085350
- 00884838085282
- 00884838099210
- 00884838099234
- 00884838099203
- 00884838085275
- 00884838099227
- 0088483808
- 00884838110571
- 00884838103276
- 00884838110564
- 00884838099
- 884838099258
- 38099234
- 84838099241
- 008848380
Recall details
- Company began the recall
- Sold in
Worldwide
- 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
- 99422
- Recall number
- Z-2931-2026
- Quantity recalled
- 10872 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
