Events

Recall of MILLENIUM MLC

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
    35306
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-12
  • 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
    When using the hd120 mlc for beam shaping and under specific treatment conditions dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose. this dosimetric property which has been discovered under very specific use conditions with dynamic fields and the hd120 mlc can lead to dose values significantly higher than expected in areas several centimeters away from the edge of the field. the effect is detectable for static mlc cases but only dynamic mlc (imrt) cases were considered to have any potential for significant unexpected dose.

Device

MILLENIUM MLC
  • Model / Serial
    Model Catalog: HD120 MLC (Lot serial: HHM0018); Model Catalog: HD120 MLC (Lot serial: H561040); Model Catalog: HD120 MLC (Lot serial: H561141)
  • Product Description
    MILLENIUM MLC
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.