Philips Azurion Interventional Fluoroscopic X-Ray System
Philips recalls Azurion X-ray systems over software issues that may cause image degradation or loss of geometry movements.
Contact Philips Medical Systems for software update instructions. Do not use the system until the software update is applied.
Recall at a glance
- Quantity recalled
- 10872 units
Why it was recalled
Philips Medical Systems Nederland B.V. is recalling certain Azurion Interventional Fluoroscopic X-Ray Systems due to two software-related issues. The software may cause image quality degradation, potentially leading to delayed therapy, procedural complications, or inappropriate treatment, and may also cause loss of geometry movements, which could delay therapy and lead to procedural complications.
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 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, 00884838099258, 00884838085251, 00884838099258, 00884838099258, 00884838099258, 00884838099241, 00884838099241, 00884838099241, 00884838099258, 00884838099241, 00884838099241, 00884838099258, 00884838085268, 00884838099272, 00884838099272, 00884838099272, 00884838099272, 00884838099272, 00884838099258
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