Events

Recall of MOSAIQ version 2.5 and above - Medical Oncology only

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Elekta Pty Ltd.

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
    RC-2015-RN-01216-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01216-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    There is a possibility of incorrect drug dosage calculation due to the following software/data item issues: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. as a separate issue, if there is a valid age limit added to an elekta metric data item (e.G. weight (kg)) and the same valid age limit has not been added to the elekta imperial data item which corresponds (e.G. weight (lb)), the calculated result which has no valid age will still be considered valid and could be used in drug dose calculations.There is a remote probability that critical harm could occur. no patient injuries have been reported so far.
  • Action
    The sponsor is advising users to implement the following workaround prior to the installation of a software update: always enter a current weight for the patient who is receiving Carboplatin on the same day or prior to the serum creatinine value being populated; Add the valid age in all Elekta data items.

Device

MOSAIQ version 2.5 and above - Medical Oncology only
  • Model / Serial
    MOSAIQ version 2.5 and above - Medical Oncology onlyARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DHTGA