Philips North America: Medical Device Recall in 2025 - (Recall #: Z-0597-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 27, 2025

Date Posted: December 17, 2025

Recall Number: Z-0597-2026

Event ID: 98052

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.

Status: Ongoing

Product Quantity: 110

Code Information:

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

Distribution Pattern:

U.S.

Voluntary or Mandated:

FDA Mandated