Events

Rappel de Panther and Panther Fusion Systems with 19-in monitor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hologic 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-2018-RN-00065-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-18
  • 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-2018-RN-00065-1
  • 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
    Hologic has been made aware that the touch screen monitor provided with certain panther and panther fusion systems has the potential for the glass panel to separate due to inadequate adhesion between the glass panel and the monitor. hologic has received 2 complaints where the glass panel separated from the panther monitor. to date, there have been no reports of injuries associated with this defect; however there is a potential risk that the glass panel may fall and injure an operator.
  • Action
    Hologic will contact affected customers to arrange for an interim solution to secure the glass panel to be installed. Subsequently, a replacement monitor with this issue corrected will be installed once made available.

Device

Panther and Panther Fusion Systems with 19-in monitor
  • Modèle / numéro de série
    Panther and Panther Fusion Systems with 19-in monitorProduct code: 902615Serial Nos: 2090002307 to 2090002532Manufactured between April 2017 and Nov 2017ARTG Number: 260039 (Gen-Probe Australia Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd