Events

Recall of ARTISTE MV - LINEAR ACCELERATOR - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS CANADA LIMITED - HEALTHCARE.

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
    62190
  • Event Risk Class
    III
  • Event Initiated Date
    2011-04-18
  • 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
    Potential safety risk related to the behavior of the 160 mlc when using the 'motion stop' button followed by `reset' several times during the treatment of one beam or one segment. as a consequence of this mlc behavior the leaf positions may vary from the originally prescribed position. therefore the remaining mu for the beam or segment may be applied to an incorrect field size and thus could result in a mistreatment (dose to wrong location).

Device

ARTISTE MV - LINEAR ACCELERATOR - MAIN UNIT
  • Model / Serial
    Model Catalog: 8139789 (Lot serial: 5414); Model Catalog: 8139789 (Lot serial: 5485)
  • Product Description
    ARTISTE ONCOR with 160-MLC
  • Manufacturer
    SIEMENS CANADA LIMITED - HEALTHCARE

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC