Events

Recall of Device Recall NuCART

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CompView Medical, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72915
  • Event Risk Class
    Class 2
  • Event Number
    Z-0644-2016
  • Event Initiated Date
    2015-12-04
  • Event Date Posted
    2016-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142497
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, digital image communications, radiological - Product Code LMD
  • 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.
  • 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.

Device

Device Recall NuCART
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US nationwide distribution including AZ, CA, CO, GA, OH, and TN.
  • Product 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.
  • Manufacturer
    CompView Medical, LLC

Manufacturer

CompView Medical, LLC
  • Manufacturer Address
    CompView Medical, LLC, 2818 E 2nd St, Suite 200, Vancouver WA 98661-7778
  • Manufacturer Parent Company (2017)
    Compview Medical Llc
  • Source
    USFDA