PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Interventional Fluoroscopic X-Ray System

Two software related issues affecting Philips Azurion R3.0 and R3.1 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.

Tags

FDA recall, medical device, class 2, Radiology, Software design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security

Source record id

Z-2932-2026

First seen by InfoSec Signals

9/23/2026

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