Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 GE Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 046 02 18 000
  • 사례 시작날짜
    2018-02-13
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12122
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. under these conditions, ge recommends the use of a sterile sheath covering the tee probe in addition to disinfection using the soak based disinfecting method or the tristel trio wipes system as described below.(see attached fsn).

Device

GE TEE probes used with Tristel Trio Wipes System
  • 모델명 / 제조번호(시리얼번호)
    GE TEE probes used with Tristel Trio Wipes System The following TEE probe models: 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS. (See Attached FSN for full details)
  • 제품 설명
    Transducer assembly
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare