Recall Z-1904-2021— Philips Medical Systems Nederlands

Name: FDA recall Z-1904-2021
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2016-06-23, terminated 2023-02-08. It names one FDA 510(k) clearance: K141979. Product: Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.. Reason: Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering..

Recalling firm: Philips Medical Systems Nederlands
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Terminated: 2023-02-08
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K141979 — ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIESPhilips Medical Systems Netherland BV·cleared 2014-08-19

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

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

Reason for recall

Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

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