Events

Rappel de Accu2ipMTA Applicator

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getz Healthcare 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-2017-RN-00759-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-21
  • 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-2017-RN-00759-1
  • 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 supplier angiodynamics has identified that the accu2i pmta applicator has the potential to not function as expected during use. the desired microwave energy will not be delivered due to coolant ingress in an electrical connection, this condition results in an error code “high reflective power” displayed on the microwave generator. please note that not all “high reflective power” error codes are a result of this failure mode, as this error code results from any instance where microwave energy is not efficiently transmitted to the tissue. although the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm to the patient; the inserted applicator will need to be removed and replaced in order to continue the procedure.
  • Action
    Customers are asked to inspect stocks, quarantine all affected units and complete the supplied Facsimile Reply Form to advise as to whether or not you still have stocks of the goods relevant to this recall.

Device

Accu2ipMTA Applicator
  • Modèle / numéro de série
    Accu2ipMTA ApplicatorProduct Codes: 900-600; 900-601; 900-602Multiple Lot NumbersARTG Number: 174514
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd