Events

Rappel de Ultrasound Transducer Norway TOE

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 GE Vingmed Ultrasound AS.

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
    22553
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    The tristel trio wipes system has been validated for efficacy and residual toxicity for tee probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans., further testing has identified a need for clarification of previously communicated disinfection guidance for ge tee probes. specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe.
  • Action
    Manufacturer to issue advice regarding use

Device

Ultrasound Transducer Norway TOE
  • Modèle / numéro de série
    Model: TEE probe models 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS, Affected:
  • Manufacturer
    GE Vingmed Ultrasound AS

Manufacturer

GE Vingmed Ultrasound AS