Surflink Media and Surflink Media 2Models: 200 and 210 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Starkey Laboratories Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-01212-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-09-20
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    Surflink Media and Surflink Media 2Models: 200 and 210Multiple Serial NumbersARTG Number: 293416
  • Manufacturer

Manufacturer