Recall of MOSAIQ

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
    101643
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-31
  • Event Country
  • 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
    Depending on mosaiq and windows operating system settings a problem can exist in mosaiq resulting in the display of an incorrect decimal symbol and/or unintended modification of numeric data by factors of 10 (multiplication by 10 100 1000 etc.). inconsistencies may also occur in date and time formats.

Device

  • Model / Serial
    Model Catalog: MOSAIQ (Lot serial: 2.50.04E1SP6 and higher)
  • Product Description
    MOSAIQ
  • Manufacturer

Manufacturer

  • Manufacturer Address
    ATLANTA
  • Manufacturer Parent Company (2017)
  • Source
    HC