Reported Jan 20, 2016 · Terminated
Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS)…
CompView Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CompView Medical, LLC · 2818 E 2nd St · Vancouver, WA · 98661-7778
Is this the product you have?
- 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.
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot# T9993-02-01 /15924CARTXXTNNA / DX00357 2 Lot# T9993-02-02 / 15924CARTXXAZPH / DX00358 3 Lot# U0328-02-02 / 15A01CARTXXCOEN /DX00360 4 Lot# U0328-02-01 / 15A26CARTXXCAK1 / DX00359 5 Lot# U0718-02-01 / 15A26CARTXXCAK2 / DX00361 6 Lot# U0718-02-02 / 15A26CARTXXCAK3 / DX00362 7 Lot# U1033-02-01 / 15A19CARTXXOHCA /DX00363 8 Lot# U1033-02-02 / 15A26CARTXXCASJ / DX00364 9 Lot# U1126-02-01 / 15A26CARTXXCAK41 /DX00365 10 Lot# U1126-02-02 / 15806CARTXXGAAT / DX00366 - Amount recalled
- 10 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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