Events

Recall of Radiometer AQURE POC 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
    14403
  • Event Initiated Date
    2013-03-25
  • 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
    Radiometer has recently become aware that patient results are displayed incorrectly in aqure when:, a) aqure is changed from the default setting for any or all parameters of international, system of units to use non international system of units (si units), and, b) the result is outside reference and critical ranges, and, c) the customer is using aqure to view the results.
  • Action
    Software to be upgraded

Device

Radiometer AQURE POC Management System
  • Model / Serial
    Model: All Radiometer analysers, Affected: Software V1.4.0 to V1.5.3
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS