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
    23031
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-19
  • 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
    Varian enhanced dynamic wedges (edw) or siemens virtual wedges (vw) files can be loaded into incorrect energies using treatment unit (tu) storing. no warning or consistency checking done for edw or vw files when adding these to the database. tu storing should not allow or should give an error message if the user attemps to add an edw or vw file for a certain energy beam to a collapsed cone model file for a different energy. currently the user is not warned when there is a mismatch.

Device

MONACO
  • Model / Serial
    Model Catalog: MONACO (Lot serial: Version 5.20.00); Model Catalog: MONACO (Lot serial: Version 5.11.01); Model Catalog: MONACO (Lot serial: Version 5.10.04); Model Catalog: MONACO (Lot serial: Version 5.10.02); Model Catalog: MONACO (Lot serial: Version 5.00.01); Model Catalog: MONACO (Lot serial: Version 5.00.04); Model Catalog: MONACO (Lot serial: Version 5.00.03); Model Catalog: MONACO (Lot serial: Version 5.00.02); Model Catalog: MONACO (Lot serial: Version 5.10.01)
  • Product Description
    MONACO
  • Manufacturer
    ELEKTA INC.

Manufacturer

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