Recall Z-0644-2016 ยท LMD System, Digital Image Communications, Radiological
CompView Medical, LLC
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.
| Date | Jan 13, 2016 (initiated Dec 4, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm began inspecting devices between 12/4/15 and 12/16/15, and sent the Nucart Product Investigation letter to consignees between 12/11/15 and 12/15/15. Consignees with questions can call the firm at 503-601-5603. |
| Quantity | 10 units |
| Distribution | US nationwide distribution including AZ, CA, CO, GA, OH, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.