Events

Recall of MONACO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA 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
    130398
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-15
  • 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 the 100% isodose value is edited on the isodose control rhe dose normalization is automatically updated. if the user does not notice this update and then rescales to the relative isoline and does not read the dose normalization value displayed on the rescale bar the rescale could be other than intended. when the user optimizes then changes the bolus assigment of the beams and then selects "calculate" (not "optimize" again) the bolus assignment to beams can get scrambled.

Device

MONACO
  • Model / Serial
    Model Catalog: MONACO (Lot serial: VERSION 5.10.00 AND HIGHER)
  • Product Description
    MONACO
  • Manufacturer
    ELEKTA INC.

Manufacturer

ELEKTA INC.
  • Manufacturer Address
    ATLANTA
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC