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
    144084
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-16
  • 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
    In a specific workflow where contours are edited and then the contour is deleted on some slices and saved in the same session it is possible that the deleted contours are still present which would not be the intent of the planner. if the patient is not saved and recalled in a subsequently created plan the bev will show the contours as still present while the transverse sagittal and coronal views will show the contours as deleted. the total volume of the structure reported in the dvh and the structure control will not match. if the study set is saved and reopened before plan creation the total volume of the structure reported in the dvh and the structure control will be corrected. a similar workflow could trigger the defect if contour deletions and edits are performed while a plan is loaded.

Device

MONACO
  • Model / Serial
    Model Catalog: MONACO (Lot serial: VERSION 3.1 AND HIGHER)
  • Product Description
    MONACO
  • Manufacturer
    ELEKTA INC.

Manufacturer

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