Z-0597-2026Class II

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

Name: Z-0597-2026 Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Creator: Philips North America
Published: 2025-10-27
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-10-27 / Open, Classified

FDA source

Philips North America began a recall of Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM on 2025-10-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0597-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-27
Posted: 2025-12-09
Recalling firm: Philips North America LLC
Product: Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips will send a customer notification to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the SSD spacer to resolve the issue.
Quantity in commerce: 110
Distribution: U.S.
Product codes and lots: Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0597-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0597-2026	Class II	Ongoing	FDA Mandated	2025-12-17	2025-12-09

Product code JAA

K200917Class IIAzurion R2.1Philips Medical Systems Nederland B.V. / cleared 2020-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)