Events

Recall of MOSAIQ

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS 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
    97083
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-07
  • 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
    Incorrect drug dosage due to "age limit" data item issue. when there is no valid (unexpired) patient weight entered on the same date or prior to a serum creatinine value being populated a stale creatinine clearance (crcl) value is being used in area under curve (auc) dose calculations.

Device

MOSAIQ

Manufacturer

ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC.
  • Manufacturer Address
    SUNNYVALE
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC