Events

Recall of Device Recall HD Still Capture

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Linvatec Corp. dba ConMed Linvatec.

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
    64647
  • Event Risk Class
    Class 2
  • Event Number
    Z-1340-2013
  • Event Initiated Date
    2013-03-18
  • Event Date Posted
    2013-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116713
  • 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
    Camera, surgical and accessories - Product Code KQM
  • Reason
    The vp1600 hd still capture image system is recalled due to an anomaly between the software code in the vp1600 console and the communications interface for various keyboard key strokes (caps lock and num lock) which may lock up and requires the user to reboot to continue.
  • Action
    The firm, ConMed, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/8/2013 to its customers after initial phone notifications. The letter identified the product, problem, and actions to be taken by the customers.

Device

Device Recall HD Still Capture
  • Model / Serial
    VP1600
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.
  • Product Description
    Ref: VP1600 HD Still Capture System ConMed Linvatec . || Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • Manufacturer Address
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA