Events

Recall of TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT

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
    99365
  • 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
    An anomaly has been identified with the truebeam and truebeam stx systems where under certain tuning conditions the electron beam emerging from the bend magnet may have an elongated spot shape. the presence of this elongated beam spot shape can be detected by a larger than expected difference in the penumbra between the radial and transverse planes as measured by beam profile scans.

Device

TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Model / Serial
    Model Catalog: TRUEBEAM (Lot serial: H191074); Model Catalog: TRUEBEAM (Lot serial: H191069); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: TRUEBEAM (Lot serial: H191044)
  • Product Description
    TrueBeam
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.