Agency classClass IIOur severity:High FDA (Devices)·Z-2932-2026·Announced 2026-08-19

Philips Azurion Fluoroscopy System Recall for Software Image Quality Issues

Philips is recalling 2,016 Azurion interventional fluoroscopic x-ray systems worldwide due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 2,016 units of the Philips Azurion interventional fluoroscopic x-ray system. The affected models are 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, running software versions R3.0 and R3.1. These devices were distributed worldwide.

The recall addresses two software-related issues. First, there is a potential for image quality degradation, which may lead to a delay in therapy, procedural complications, and/or inappropriate treatment. Second, there is a potential loss of geometry movements, which may lead to a delay in therapy and procedural complications.

This recall is classified as FDA Class II. No specific instructions for consumers are provided in the source text, but the recall is intended to address the identified software defects in these medical imaging systems.

The recalled product

Product: 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
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Interventional Fluoroscopic X-ray System
Hazard: software-defect
image-quality-degradation
procedural-complications
Affected units: 2,016

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI: (01)00884838116757(21)5
(01)00884838116771(21)686
(01)00884838116771(21)521
(01)00884838116771(21)812
(01)00884838116771(21)163
(01)00884838116801(21)127
(01)00884838116757(21)34
(01)00884838116733(21)61
(01)00884838116764(21)226
(01)00884838116771(21)327
(01)00884838116764(21)277
(01)00884838116771(21)780
(01)00884838116771(21)429
(01)00884838116764(21)276
(01)00884838116788(21)87
(01)00884838116801(21)37
(01)00884838116771(21)362
(01)00884838116771(21)502
(01)00884838116740(21)77
(01)00884838116757(21)106

Distribution

Distribution scope not specified by the agency.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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