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Recall Observatory FDA recall evidence

Device 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.

Z-0644-2016

December 04, 2015

Class II

Product summary

Firm
CompView Medical, LLC
Event
Event 72915
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0644-2016

Official wording

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.

Code information: Lot# T9993-02-01 /15924CARTXXTNNA / DX00357 Lot# T9993-02-02 / 15924CARTXXAZPH / DX00358 Lot# U0328-02-02 / 15A01CARTXXCOEN /DX00360 Lot# U0328-02-01 / 15A26CARTXXCAK1 / DX00359 Lot# U0718-02-01 / 15A26CARTXXCAK2 / DX00361 Lot# U0718-02-02 / 15A26CARTXXCAK3 / DX00362 Lot# U1033-02-01 / 15A19CARTXXOHCA /DX00363 Lot# U1033-02-02 / 15A26CARTXXCASJ / DX00364 Lot# U1126-02-01 / 15A26CARTXXCAK41 /DX00365 Lot# U1126-02-02 / 15806CARTXXGAAT / DX00366

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.