Events

Rappel de Muse_Halo2_Z-Series (BTE)

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 Starkey Laboratories Inc.

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
    23315
  • Date de mise en oeuvre de l'événement
    2018-07-11
  • 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: Starkey Laboratories New Zealand, Unit 1, 710 Great South Road, Penrose, Auckland 1061
  • Cause
    It has recently been reported that an unattended child aged 7 months has required treatment to remove an earmould from the larynx. to ensure the safeguarding of the products the manufacturer has taken new steps to further improve the safety of the earmoulds for young children and have implemented a successful method of securing a tube into a silicone earmould with a bonding glue to prevent the detachment of the earmould.
  • Action
    Product to be modified

Device

Muse_Halo2_Z-Series (BTE)

Manufacturer

Starkey Laboratories Inc