Events

Retiro De Equipo (Recall) de Surflink Media and Surflink Media 2Models: 200 and 210

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Starkey Laboratories Australia Pty Ltd.

¿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
    RC-2017-RN-01212-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-09-20
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01212-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    It has recently come to starkey laboratories' attention that specific surflink media and surflink media 2 accessories may be operating outside their permissible frequency band (915-928 mhz), and may cause interference with mobile towers (operating in the frequency band 902-915 mhz). any potential interference to mobile towers does not cause any interference or disruption to the accessories themselves. that is, the accessories continue to fully function/operate even though they may operate outside the frequency band 915-928 mhz.
  • Acción
    1. Retailers are to quarantine affected stock then complete and return the supplied acknowledgment form. 2. Affected units should be returned as directed to Starkey Laboratories Australia. 3. Retailers are requested to forward the supplied letter to customers along with a partially-completed acknowledgement form for the customers actioning. 4. End-users should complete the supplied Recall for product Correction form, then return the accessory (not the hearing aid) to Starkey directly (using the prepaid bag), or return the accessory to the clinic where it was purchased. 5. Starkey will update the firmware and return the units to customers.

Device

Surflink Media and Surflink Media 2Models: 200 and 210

Manufacturer

Starkey Laboratories Australia Pty Ltd