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
    105845
  • 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
    The 4ditc ad-hoc imaging ciao (complete irradiated area outline) calculation results in a ciao shape that differs from the ciao calculated in ariachart eclipse offline review and on-board imager. the 4ditc algorithm adds dose for the control point at the field edge which should not be added according to the system specifications. this error will be present in the 4ditc mlc display. the discrepancy is a display issue that is only seen when an ad-hoc image template has been added after the plan has been loaded on the 4ditc. if the 4ditc generated ciao image is projected on the patient using the light field the incorrect field edge will be displayed. if the field edge is used to set-up another abutting treatment field the area between the projected field edge and the abutting field edge would be mismatched and not treated.

Device

TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Model / Serial
    Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: TRUEBEAM (Lot serial: H191074); Model Catalog: V8.8 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.6 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.8 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.6 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.1.2 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.1.2 (Lot serial: >10 SERIAL NUMBERS.)
  • Product Description
    TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.