Recall of ARTISTE MV - LINEAR ACCELERATOR - SYNGO RT THERAPIST

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
    15144
  • Event Risk Class
    III
  • Event Initiated Date
    2009-11-06
  • Event Country
  • 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
    Two or more treatment plans with different isocenter positions are stored together in one course in lantis e.G. main treatment plan and boost plan. if the cone beam is acquired using calculation of table shift coordinates will be based 0n isocenter postion. this will lead to an incorrect table shift.

Device

  • Model / Serial
    Model Catalog: 08162815 (Lot serial: 10040); Model Catalog: 08162815 (Lot serial: 10003); Model Catalog: 08162807 (Lot serial: 10048); Model Catalog: 08162807 (Lot serial: 10024)
  • Product Description
    ARTISTE MV-SYNGO RT THERPIST
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
  • Source
    HC