FDA recall Z-1933-2020

Philips North America, LLC · Class II · device

Product

Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.

Reason for recall

When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of MD and MI. The countries of Austria, Belgium, France, Germany, Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.

Key facts

Status
Terminated
Initiation date
2020-04-10
Report date
2020-05-20
Termination date
2021-01-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1933-2020