FDA recall Z-0597-2026

Philips North America · Class II · device

Product

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

U.S.

Key facts

Status: Ongoing
Initiation date: 2025-10-27
Report date: 2025-12-17
Voluntary/Mandated: FDA Mandated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2026