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
    110423
  • Event Risk Class
    III
  • Event Initiated Date
    2009-03-17
  • Event Country
  • 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
    Dell x5 handheld computer will freeze upon interrogation due to inability of microsoft pc 2002 os to locate the flash memory directory on dell x5 computer. once frozen device becomes non-responsive to inputs.

Device

  • Model / Serial
    Model Catalog: 250 V7.1.4 (Lot serial: > 10 devices contact); Model Catalog: 250 V7.1.4 (Lot serial: manufacturer)
  • Product Description
    VNS THERAPY SYSTEM-PROGRAMMING SOFTWARE
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC