Events

Surf Link Media 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Starkey Laboratories Inc 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
    22259
  • 사례 시작날짜
    2017-11-15
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Recalling Organisation: Starkey Laboratories New Zealand, Unit 1, 710 Great South Road, Penrose, Auckland 1061
  • 원인
    The manufacturer has recently become aware that the 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
    Software to be upgraded

Device

Surf Link Media
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Surflink Media or Surflink Media 2 (Models 200 or 210)
  • Manufacturer
    Starkey Laboratories Inc

Manufacturer

Starkey Laboratories Inc