Events

Recall of VP 1600 HD STILL CAPTURE SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CONMED CANADA.

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
    89971
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Through the conmed linvatec complaint system conmed linvatec has received sporadic complaints where the vp1600 still capture console software may give the appearance of being fully locked up but is actually unresponsive with certain keyboard inputs. the vp1600 is still fully functional and presents a full motion image on the main display monitor but may not be able to capture a still image frame (picture) for record storage purposes using the keyboard. the user can still capture a still image using the camera head unit. the user may also feel compelled to turn off and reboot the system which will render a display loss during the rebooting process. this is a still image capture system without any direct patient contact.

Device

VP 1600 HD STILL CAPTURE SYSTEM
  • Model / Serial
    Model Catalog: VP1600 (Lot serial: All serial numbers)
  • Product Description
    HD STILL CAPTURE SYSTEM
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC