Recall of Muse_Halo2_Z-Series (BTE)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Starkey Laboratories Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Starkey Laboratories New Zealand, Unit 1, 710 Great South Road, Penrose, Auckland 1061
  • Reason
    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