Events

Rappel de Draeger Jaundice Meter JM 103

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 Draeger Medical Systems Inc.

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
    22800
  • Date de mise en oeuvre de l'événement
    2018-04-11
  • 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: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Cause
    Post market surveillance has shown that some users have concerns about the method used by jaundice meters jm-103 and/or jm-105 to indicate that a taken measurement is out of range. as described in the instructions for use manual and in the device's training materials:, jaundice meter model jm-103 displays a blinking "- - -" when the measurement is out of range. the measuring range is defined to 340 µmol/l., jaundice meter model jm-105 displays a blinking "- 0 -" when the measurement is out of range. the measuring range is defined to 340 µmol/l.
  • Action
    Manufacturer to issue advice regarding use

Device

Draeger Jaundice Meter JM 103

Manufacturer

Draeger Medical Systems Inc