Recall Z-2485-2023— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-2485-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-30

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2023-06-30. It names 2 FDA 510(k) clearances: K200917, K161563. Product: Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems. Reason: Loss of availability of the wireless foot switch during procedures..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-30
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

2 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01
K161563 — Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.·cleared 2016-07-29

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

Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

Reason for recall

Loss of availability of the wireless foot switch during procedures.

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