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
    105119
  • Event Risk Class
    II
  • Event Initiated Date
    2010-12-30
  • 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
    For vmat plans the qa (measured) dose is lower than monaco's calculated dose. overestimation of dose in the treatment field is in the order of 5%.

Device

MONACO RTP SYSTEM - VMAT OPTION

Manufacturer

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