Recall Z-2669-2016— Philips Electronics North America Corporation

Name: FDA recall Z-2669-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-07

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-07-07, terminated 2020-07-14. It names one FDA 510(k) clearance: K141979. Product: Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table, 722039; Allura Xper FD20/15, 722058; Allura Xper FD20/15 OR Table, 722059. Reason: Increase in the failure rate of certain low-voltage DC power supplies (DCPS).

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Terminated: 2020-07-14
Firm location: Andover, MA, United States

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

Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table, 722039; Allura Xper FD20/15, 722058; Allura Xper FD20/15 OR Table, 722059

Reason for recall

Increase in the failure rate of certain low-voltage DC power supplies (DCPS)

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