FDA recall, , Moderate risk
Philips Allura and Azurion X-Ray Systems
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Summary by Recall Canary from the FDA notice
What happened
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling certain Philips Allura and Azurion Interventional Fluoroscopic X-Ray Systems due to potential loss of imaging functionality, loss of motorized movement, or loss of data caused by unauthorized Hard Disk Drives. The recall began on June 17, 2026, and was added to the FDA's Enforcement Report on August 5, 2026, with US Nationwide distribution.
2 photos
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 Allura, Cardio Vascular-Allura Centron.
- Model
- 722400
- UDI-DI
- 00884838042315
722033
- Model
- 722033
722001
- Model
- 722001
722025
- Model
- 722025
722029
- Model
- 722029
722058
- Model
- 722058
722059
- Model
- 722059
722038
- Model
- 722038
722039
- Model
- 722039
722065
- Model
- 722065
722066
- Model
- 722066
722227
- Model
- 722227
Philips Azurion under
- UDI-DI
- 00884838085275
- 00884838099203
- 00884838085282
- 00884838099210
- 00884838103276
- 00884838099227
- 00884838099234
- 00884838110564
- 00884838085350
- 00884838099265
- 00884838085367
- 00884838099272
- 0884838099272
- 00884838085251
- 00884838099241
- 00884838085268
- 00884838099258
- 00884838110571
Philips Allura under
- UDI-DI
- 00884838059030
- 00884838054189
- 00884838054233
- 00884838059047
- 00884838054196
- 00884838059054
- 84838059054
- 00884838054202
- 23040202
- 00884838059061
- 00884838059108
- 00884838059085
- 00884838054240
- 00884838054219
- 00884838059115
- 00884838059122
- 00884838054226
- 884838054226
- 00884838054271
- 00884838083431
- 00884838083448
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
- 99313
- Recall numbers
- Z-2891-2026 to Z-2893-2026
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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
