Events

Recall of VNS THERAPY SYSTEM - PROGRAMMING SOFTWARE - MODEL 250

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

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
    105145
  • Event Risk Class
    III
  • Event Initiated Date
    2009-02-24
  • 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
    Vns therapy generators may be inadvertently programmed to 8.0 milliamps.

Device

VNS THERAPY SYSTEM - PROGRAMMING SOFTWARE - MODEL 250
  • Model / Serial
    Model Catalog: 250 (Lot serial: VERSIONS 6.1 7.0 7.1.3)
  • Product Description
    SEE 33-01
  • Manufacturer
    XYCORP MEDICAL INC.

Manufacturer

XYCORP MEDICAL INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC