Recall Z-0644-2016— CompView Medical, LLC
Class II · Terminated
Class II FDA medical device recall by CompView Medical, LLC, initiated 2015-12-04, terminated 2016-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- CompView Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-04
- Terminated
- 2016-03-31
- Firm location
- Vancouver, WA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.