Events

Rappel de Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator

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 AngioDynamics Inc (US).

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
    21545
  • Date de mise en oeuvre de l'événement
    2017-06-15
  • 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: Getz Healthcare Limited, 2/20 Beatrice Tinsley Crescent, Albany, Auckland
  • Cause
    Manufacturer is recalling the accu2i pmta hyeprthermia system applicator as a potential failure mode has been identified of the tubing coolant line developing a leak within the applicator system which causes a "high reflected power" fault condition that makes the applicator inoperable to deliver microwave energy., hazard 1: applicator will not deliver power due to high reflected power fault condition., hazard 2: applicator's cooling line leaks cooling fluid within the applicator shaft., while the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm, the inserted applicator would need to be removed.
  • Action
    Product to be returned to supplier

Device

Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator
  • Modèle / numéro de série
    Model: 900-600; 900-601; 900-602, Affected: Various Lot numbers
  • Manufacturer
    AngioDynamics Inc (US)

Manufacturer

AngioDynamics Inc (US)