Events

Recall of Surflink Media and Surflink Media 2Models: 200 and 210

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Starkey Laboratories Australia Pty Ltd.

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
    Recall
  • Event ID
    RC-2017-RN-01212-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-09-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01212-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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