Philips Azurion Interventional X-Ray System
Philips recalls Azurion x-ray systems over software issues that may delay therapy or cause complications.
Contact Philips Medical Systems to obtain the software update or corrective action for your Azurion system. Do not delay therapy; discuss any concerns with your healthcare provider.
Recall at a glance
- Quantity recalled
- 2016 units
Why it was recalled
Philips is recalling the Azurion interventional fluoroscopic x-ray system due to two software issues affecting R3.0 and R3.1 systems. The issues may cause image quality degradation or loss of geometry movements, potentially leading to delayed therapy, procedural complications, or inappropriate treatment.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
- UDI-DI
- 00884838116757, 00884838116771, 00884838116771, 00884838116771, 00884838116771, 00884838116801, 00884838116757, 00884838116733, 00884838116764, 00884838116771, 00884838116764, 00884838116771, 00884838116771, 00884838116764, 00884838116788, 00884838116801, 00884838116771, 00884838116771, 00884838116740, 00884838116757
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Software Defect recalls
Other recent recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Editorial summary by Recall Canary · summary updated 2026-08-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification