Events

Retiro De Equipo (Recall) de Muse_Halo2_Z-Series (BTE)

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Starkey Laboratories Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    23315
  • Fecha de inicio del evento
    2018-07-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Starkey Laboratories New Zealand, Unit 1, 710 Great South Road, Penrose, Auckland 1061
  • Causa
    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.
  • Acción
    Product to be modified

Device

Muse_Halo2_Z-Series (BTE)

Manufacturer

Starkey Laboratories Inc