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
    17141
  • Event Risk Class
    I
  • Event Initiated Date
    2012-07-02
  • 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
    If the dicom coordinates option is turned on in the reports pull down menu the following issues are seen on the resulting print out issue 1 the coordinates will be in dicom space thus not matching the setup reference dialog. issue 2 the shift coordinates are reported incorrectly.

Device

MONACO
  • Model / Serial
    Model Catalog: MONACO (Lot serial: SW version 3.10.00-3.20.00); Model Catalog: FOCAL SIM (Lot serial: SW version 4.64.00-4.70.00)
  • Product Classification
    Radiology Devices
  • Product Description
    MONACO radiation treatment planning software Ver 3.10.00-3.20.00
  • Manufacturer
    ELEKTA INC.

Manufacturer

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