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Terminated

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.

FDA Recall Z-0644-2016 · Posted 2016-01-13

Recalling FirmCompView Medical, LLC
Recall StatusTerminated
Product CodeLMD
Date Initiated2015-12-04
Date Terminated2016-03-31
Product Quantity10 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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