Recall of GAMMAMED 12I GAMMA IRRADIATION INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VARIAN MEDICAL SYSTEMS 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
    86468
  • Event Risk Class
    II
  • Event Initiated Date
    2004-02-06
  • 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
    Software error that lead to incorrect factor transmitted to the gammamed and the computer used the wrong factor to calculate the treatment time.

Device

  • Model / Serial
    Model Catalog: 891 (Lot serial: serial number mandatory 891); Model Catalog: 891 (Lot serial: 935100 (MODEL NUMBER)); Model Catalog: 891 (Lot serial: ); Model Catalog: 891 (Lot serial: 0)
  • Product Description
    gammamed 12i
  • Manufacturer

Manufacturer