Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Date of Enforcement Report: 8/10/2026
Class: II

PRODUCT

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

Recall Number:

Z-2931-2026

REASON:

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

RECALLING FIRM/MANUFACTURER:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

VOLUME:

10872 units

DISTRIBUTION:

Worldwide