Recall Z-2134-2025— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-2134-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-04

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-06-04. It names 3 FDA 510(k) clearances: K181830, K172822, K163715. Product: Azurion 7 M20. Fluoroscopic X-Ray System.. Reason: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-04
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

3 on FDA's record

K181830 — Azurion R2.0Philips Medical Systems Nederland B.V.·cleared 2018-08-02
K172822 — Azurion series R1.2Philips Medical Systems Nederland B.V.·cleared 2017-11-22
K163715 — Allura Xper R9Philips Medical Systems Nederland B.V.·cleared 2017-01-26

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 7 M20. Fluoroscopic X-Ray System.

Reason for recall

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

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