CLASS II ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report

Azurion R3.0 recalled by Philips North America

Philips North America is recalling Azurion R3.0. The recall was initiated on 27 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016

Quantity recalled110

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0597-2026
FDA event ID: 98052
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Oct 2025
FDA classified: 9 Dec 2025
Reported: 17 Dec 2025
Type: FDA Mandated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

27 Oct 2025	Recall initiated by company
9 Dec 2025	Classified by FDA	+43 days
17 Dec 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Product as listed by the FDA

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Where it was distributed

U.S.

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016

Where was it sold?

U.S.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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