FDA recall, , Moderate risk
Philips Azurion 3M12, 3M15, 5M12 and Other Angiography Systems
Philips Azurion systems may show a dark image during Roadmap Pro, not clinically usable.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V. is recalling certain Philips Azurion products with Roadmap Pro Software because, during the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap, which may cause a dark image with the next fluoroscopy run. The recall began on December 7, 2023, and was classified by the FDA on June 1, 2026. The products were distributed nationwide in the US.
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?
8 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838085282
- 00884838099210
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838099265
- 00884838085350
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838085367
- 00884838099272
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838099234
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838099241
- 00884838085251
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838099203
- 00884838085275
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838099227
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- UDI-DI
- 00884838099258
- 00884838085268
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- Hazard
- Device 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
- 98977
- Recall numbers
- Z-2284-2026 to Z-2291-2026
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
