Events

Rappel de Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2014-RN-00736-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-04
  • 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-2014-RN-00736-1
  • 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
    Haag streit has identified a potential issue with the slide-in adaptor plug for the perkins mkiii tonometer charger. an incident was reported to haag-streit where the use of the adaptor tripped a customer’s circuit breaker. upon investigation it was found the adaptor contained an electrical fault. this electrical fault has the potential to cause arcing within the adaptor, which poses a potential fire hazard. the risk when using the adaptor is most apparent if the adaptor is used in an un-fused circuit. the risk of harm and damage can be reduced if the unit is plugged into a conforming power outlet with a circuit breaker.
  • Action
    Users are advised to isolate the affected Plug Adaptors from use. A DTA representative will contact users in regards to replacement of affected stock.

Device

Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer
  • Modèle / numéro de série
    Slide-in Plug Adaptor for Charger used with Haag Streit UK Perkins MkIII Tonometer Tonometer Product Code: CC-5806004Serial Numbers: 274, 275, 276, 731, 732, 733, 453, 490, 452, 360ARTG Number: 151673
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd