Events

Recall of MONACO RTP SYSTEM - VMAT OPTION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC 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
    87437
  • Event Risk Class
    I
  • Event Initiated Date
    2013-02-11
  • 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
    When an arc based plan is created the beam will have a default rotation start angle. if the start angle for the arc is edited and then the plan delivery type is changed to a non-arc beam the rotation start angle does not update as it should. the result is that the beam is displayed at the gantry angle but the dose is calculated at the rotation start angle.

Device

MONACO RTP SYSTEM - VMAT OPTION

Manufacturer

ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC.
  • Manufacturer Address
    SUNNYVALE
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC