Events

Recall of ConMed Linvatec Surgical Video Cart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Conmed Linvatec Endoscopy Division.

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
    48195
  • Event Risk Class
    Class 2
  • Event Number
    Z-2458-2008
  • Event Initiated Date
    2007-10-31
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70983
  • 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
    Surgical camera and accessories - Product Code KQM
  • Reason
    The recall was initiated because conmed linvatec has determined there is a possibility the wheel caster(s) may become loose which may result in the wheel caster(s) falling out of the base of the vp8500 video cart. the potential for the wheel caster or casters to fall out of the base of the cart may result in a potential tip hazard.
  • Action
    The recall was initiated by the firm sending the recall information packet via UPS overnight delivery to the Distribution and Sales Force in May 2008. The packet included: 1. Recall Notification and reply form for each consignee. 2. Instructions on the procedure to conduct the recall of the VP8500. 3. A list of affected consignees in their territory. The Recall Notification informed the customers of the potential for the wheel caster(s) to fall out of the base of the cart which may result in a potential tip hazard. The customers were instructed to discontinue the use of the VP8500 Video Cart immediately if the wheel caster(s) show any signs of being loose and to complete the recall reply form. Upon receipt of notification, distributors are supposed to : 1. Visit the affected accounts and provide them with a copy of the Recall Notification to inform them of the recall and the Recall Acknowledgment Reply Form which is to be mailed or faxed back to the firm. 2. Schedule the delivery and installation of refurbished carts to replace the recalled cart(s) by contacting Jill Cover, ConMed Linvatec Endoscopy Division at (888) 292-0100, ext. 8157 or e-mail jcover@livatec.com to arrange for replacement. 3. Move medical devices, etc. from the recalled cart(s) and set up the refurbished cart(s) with the required equipment at the account's location. (ProMEDICA will arrange for shipping of the recalled cart(s) back to ProMEDICA.)

Device

ConMed Linvatec Surgical Video Cart
  • Model / Serial
    Catalog Number: VP8500;   Serial #;s: 6080185, 6080285, 6080385, 6080485, 6080585, 6080685, 6080785, 6080885, 6080985, 6081085, 6081185, 6081285, 6081385, 6081485, 6081585, 6081685, 6081785, 6081885, 6081985, 6082085, 6082185, 6082285, 6082385, 6082485, 6082585, 6082685, 6082785, 6082885, 6082985, 6083085, 6083185, 6083285, 6083385, 6083485, 6083585, 6083685, 6083785, 6083885, 6083985, 6084085, 6090185, 6090285, 6090385, 6090485, and 6090585.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including states of: AK, AZ, CA, FL, GA, IL, IN, KS, MD, NC, NY, OH, and PA and country of Canada.
  • Product Description
    ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500
  • Manufacturer
    Conmed Linvatec Endoscopy Division

Manufacturer

Conmed Linvatec Endoscopy Division
  • Manufacturer Address
    Conmed Linvatec Endoscopy Division, 7416 Hollister Ave, Goleta CA 93117-2583
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA