Events

Mako RIO System Ethernet to Fiber Optic Converter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2018-RN-00100-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00100-1
  • 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
    Stryker has discovered that certain ethernet to fibre optic converters did not pass testing due to a rio connection error. a rio connection error will occur when communication is lost between the rio and the guidance module. in the event a mako system experiences a rio connection error, a network connection error message will appear on the system display.
  • 조치
    Stryker will arrange replacement of all Ethernet to Fibre Optic Converters of affected units with updated converters.

Device

Mako RIO System Ethernet to Fiber Optic Converter
  • 모델명 / 제조번호(시리얼번호)
    Mako RIO System Ethernet to Fiber Optic ConverterItem Number: 200933 All lot numbers are affectedARTG Number: 223105 (Stryker Australia Pty Ltd - Robot, surgical, navigation unit)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA