Events

Rappel de Surflink Media and Surflink Media 2Models: 200 and 210

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Starkey Laboratories Australia Pty Ltd.

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
    RC-2017-RN-01212-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-09-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01212-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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