🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: December 4, 2015 CompView Medical Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CompView Medical, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0644-2016