Home / Recalls / Philips North America / Z-0597-2026

Z-0597-2026 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
December 17, 2025
Initiation Date
October 27, 2025
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
110

Product Description

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

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.

Distribution Pattern

U.S.

Code Information

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

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  • Z-1204-2026 Class II — Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR syst (December 3, 2025)