CompView Medical, LLC recalls Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) e…

Recall date

December 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0644-2016

FDA classification

Class II

Brand / firm

CompView Medical, LLC

Sold / distributed

US nationwide distribution including AZ, CA, CO, GA, OH, and TN.

Why it was recalled

The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release and detach.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.