Events

Recall of GAMMAMED PLUS

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
    85737
  • Event Risk Class
    I
  • Event Initiated Date
    2006-04-13
  • 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
    Possibility for a communication error to occur between the gammamed afterloader dev. and the pc monitoring console with a resulting discrepancy between the recorded real irradiation times and the recorded times.

Device

GAMMAMED PLUS
  • Model / Serial
    Model Catalog: 930520 (Lot serial: GM0E139 GMGM0E144 GM0A054); Model Catalog: 930520 (Lot serial: GM0A068); Model Catalog: 930520 (Lot serial: GM3185969501000 GM0D135); Model Catalog: 930520 (Lot serial: GM00253 GM0E140 GM0E143)
  • Product Description
    GAMMAMED PLUS
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.