Events

Recall of Elekta Mosaiq 2.5

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by 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
    19557
  • Event Initiated Date
    2015-12-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • 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 the curve (auc) dose calculations., incorrect drug dosage due to patient weight data item issue:, if there is a valid age limit added to an elekta metric data item (eg; weight (kg)) and the same valid age limit has not been added to the elekta imperial data item which corresponds (eg; weight (lb) ), the calculated result which has no valid age will still be considered valid and could be used in drug calculations., if a stale dose calculation is used in dose calculations the dose may be incorrect.
  • Action
    Software to be upgraded

Device

Elekta Mosaiq 2.5

Manufacturer

Impac Medical Systems Inc
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NZMMDSA