Recall Z-0597-2026— Philips North America

Name: FDA recall Z-0597-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-27

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2025-10-27. It names one FDA 510(k) clearance: K200917. Product: Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM. Reason: 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..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2025-10-27
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.