FDA recall Z-1492-2020

Philips North America, LLC · Class II · device

Product

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

Nationwide domestic distribution. Foreign distribution worldwide.

Key facts

Status: Terminated
Initiation date: 2019-12-30
Report date: 2020-03-25
Termination date: 2022-11-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1492-2020