Events

Recall of MULTILEAF COLLIMATOR

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
    47235
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-16
  • 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
    Failure to retract or park the varian mlc leaves prior to use of the demountable brainlab m3 could result in the varian mlc leaves interfering with treatment field defined by brainlab m3 without an interlock being asserted. when a demountable brainlab m3 mlc is installed on a varian accelerator the use of two a-b switches is required to deploy the desired mlc. both switches must be set to the correct position prior to use. the first a-b switch box connects the mlc workstation to either the varian mlc controller or to the brainlab m3 controller. the second a-b switch box connects the clinac console to either the varian mlc controller or the brainlab m3 controller. this connection includes the mlc interlock used to inhibit radiation from the clinac accelerator. the mlc that is not selected on this a-b switch is disconnected from the interlock circuitry.

Device

MULTILEAF COLLIMATOR
  • Model / Serial
    Model Catalog: MLC 52 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542533); Model Catalog: MLC 52 (Lot serial: H542533); Model Catalog: MILLENIUM 80 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542182); Model Catalog: MLC 52 (Lot serial: H542182)
  • Product Description
    MULTILEAF COLLIMATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.