Events

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
    21390
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-12
  • 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
    Retention of outdated information in an order set. it is possible that a change to an order set will not be saved in the current open care plan when the following work flow is utilized: 1-open either the care plan edit form or the care plan instance form and leave the form open. 2-select an order set that is part of the same care plan and make a change to the order set. this can be changed to the order set name and label or a change to the drug dose administration instructions etc. 3-the update made to the order set will not be saved in the current open care plan.

Device

MOSAIQ
  • Model / Serial
    Model Catalog: MOSAIQ (Lot serial: VERSION 2.50.05 AND HIGHER)
  • Product Description
    MOSAIQ
  • Manufacturer
    ELEKTA INC.

Manufacturer

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