Events

Rappel de Radiometer AQURE Data Management System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Radiometer Medical ApS.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19628
  • Date de mise en oeuvre de l'événement
    2016-01-13
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Cause
    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
  • Modèle / numéro de série
    Model: , Affected: , Software version: all software versions below V2.1.1
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS