Events

Recall of MOSAIQ with Locate

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
    20410
  • Event Initiated Date
    2016-07-19
  • 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
    It is possible that a change to an order set will not be saved in the current, open care plan when the following workflow 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 a change to the order set name or 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.
  • Action
    Software to be upgraded

Device

MOSAIQ with Locate

Manufacturer

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