Events

Rappel de PRN 50-M+ Digital Writer

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty Ltd.

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
    RC-2016-RN-00149-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00149-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has recently become aware of a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. there is an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the prn 50-m+ digital writer to meet its intended flammability and fluid ingress rating.
  • Action
    GE Healthcare is replacing all affected printers with unaffected units. This action has been closed-out on 22/02/2017.

Device

PRN 50-M+ Digital Writer
  • Modèle / numéro de série
    PRN 50-M+ Digital Writer Part Number: 600-23310-01 Units manufactured from May 28, 2013 through to April 7, 2015Serial Numbers: 1801405 through 1918761ARTG Number: 117497
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd