Events

Recall of Radiometer AQURE Data Management System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Radiometer Medical ApS.

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
    19628
  • Event Initiated Date
    2016-01-13
  • 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: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Reason
    Manufacturer has recently become aware of a potential clinical issue with aqure if the data management system is being used to interpret patient results for the management of treatment., in aqure, there are two views called flexlink and patient view. each can display multiple patient result values from a single patient, provided over time, from one or multiple devices. this screen is intended to be reviewed by a clinician., the issue occurs when a sample type is not provided from a device. an example is where results from a sample type of “urine” (not displayed) is compared to results from a sample type “arterial”. in this case a clinician may incorrectly take action based on an assumption that all results are from a sample type “arterial”.
  • Action
    Software to be upgraded

Device

Radiometer AQURE Data Management System
  • Model / Serial
    Model: , Affected: , Software version: all software versions below V2.1.1
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS