Recall Z-1486-2020— Philips North America, LLC

Name: FDA recall Z-1486-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-30

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-12-30, terminated 2022-11-17. It names one FDA 510(k) clearance: K141979. Product: Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.. Reason: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-12-30
Terminated: 2022-11-17
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 Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

Reason for recall

A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

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