Official recall notice

FDA DeviceClass IINotable

FDA Recall: Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236,

Recall date
2026-08-19
FDA class
Class II

Why it was recalled

Hazard

Two software related issues: 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

Recommended action

What to do

2016 units

Product description

Two software related issues: 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

Verify with the official notice →
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