UroDiagnost Eleva, system code 708033
FDA Recall #Z-1492-2020 — Class II — December 30, 2019
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.
Recalling Firm
Philips North America, LLC — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Code Information
Serial numbers 64 48 2 60
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated