Recall Z-1492-2020— Philips North America, LLC

Name: FDA recall Z-1492-2020
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: K911098. Product: UroDiagnost Eleva, system code 708033. 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

K911098 — PHILIPS URO DIAGNOST MRFPhilips Medical Systems, Inc.·cleared 1991-07-03

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

UroDiagnost Eleva, system code 708033

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.