E.CAM SIGNATURE SERIES MARK SIEMENS - Camera Camcorder - Model E.CAM Signature Series, brand SIEMENS - Registration 10234230040 ### SPECT SYSTEM (Nuclear Image Formation System) - Symbia Model E; Symbia S - Record 10345161991 - VIEW PRODUCT DESCRIPTION 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1849
  • 날짜
    2016-03-30
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    According to the company: "Recommendation to users and patients: We recommend the users of the target devices of this field action to inform all responsible staff about these reinforcements of instructions that were made in the user manual. Continued use of the system is not impaired, meaning users can continue to use the systems. Also, we ask that users make sure that this safety information has been attached to the instructions for using the system. Finally, we always warn that all information regarding the use of systems should be available to all operators of the equipment. "
  • 원인
    Siemens healthcare informs that it has received complaints regarding incidents, which during the exchange of collimator activities have resulted in injury to the operator. it has been determined that while the existing user's manual is correct, additional add-ins with visual aids may promote clarity and appropriately emphasize the collimator process exchange.
  • 조치
    The action of field code MI005 / 16 / S initiated by Siemens deals with a Letter to the Client, SEE LETTER TO CUSTOMERS AND DISTRIBUTION MAP.

Manufacturer