Events

Recall of OPTIVANTAGE DH INJECTOR- MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TYCO HEALTHCARE GROUP 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
    17286
  • Event Risk Class
    II
  • Event Initiated Date
    2006-11-08
  • 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
    Software anomaly in which the flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head.

Device

OPTIVANTAGE DH INJECTOR- MAIN UNIT
  • Model / Serial
    Model Catalog: 844001 (Lot serial: )
  • Product Description
    OPTIVANTAGE DUAL HEAD INJECTORS
  • Manufacturer
    TYCO HEALTHCARE GROUP CANADA

Manufacturer

TYCO HEALTHCARE GROUP CANADA
  • Manufacturer Address
    POINTE-CLAIRE
  • Source
    HC