Events

Recall of ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConMed Linvatec Australia Pty Ltd.

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
    RC-2013-RN-00224-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00224-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has determined there is potential for the keyboard to lockup during operation due to a software issue in the vp1600 console. if during use the caps lock/num lock is pressed, the vp1600 software could potentially give the appearance of being locked up, but is actually unresponsive only to keyboard inputs. the vp1600 is still presenting a live image on the main display but may not be able to capture an image frame for record storage using the keyboard.
  • Action
    Please contact ConMed Linvatec Australia to schedule a return date for repairing the affected unit. A loan unit will be provided by ConMed Linvatec if needed during the repair. VP1600 can continued to be used until repaired if the manufacturer’s recommendations and instructions detailed in the Product Manual, for the safe handling and use of the device is followed.

Device

ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)
  • Model / Serial
    ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)Affected Serial numbers: 75659, 75804, 76126, 75805, 76116, 12008, 72902, 76009, 12043, 12036, 75657, 75658 and 12015ARTG: 126243
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd