Z-1492-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
March 25, 2020
Initiation Date
December 30, 2019
Termination Date
November 17, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4

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.

Distribution Pattern

Nationwide domestic distribution. Foreign distribution worldwide.

Code Information

Serial numbers 64 48 2 60