Events

Recall of AVATAR SC-5

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

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
    21861
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-30
  • 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
    Until conducted by health canada on may 202013 the avatar sc-5 was marketed as a scientific instrument. the product was classified in concurrence with the medical devices bureau as a class ii medical device by rule 10(1) of the regulations. the product has not been marketed and sold in full compliance with the requirements of the food and drugs act and medical devices regulations.

Device

AVATAR SC-5
  • Model / Serial
    Model Catalog: AVATAR SC-5 (Lot serial: NOT APPLICABLE)
  • Product Description
    AVATAR SC-5
  • Manufacturer
    VERADYNE CORPORATION

Manufacturer

VERADYNE CORPORATION