Events

SYSTEM DIMENSION EXL - Registration nº 10345161695. Serial Numbers: 12251428; 12252714. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnóstics 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
    1763
  • 날짜
    2015-12-01
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The company informs that the absence of the safety cover can cause a risk of electric shock to the operator. This question does not affect patient outcomes.
  • 원인
    Siemens healthcare has identified that in some rms refrigeration compressors, safety cover may be missing, in the electrical termination block. exposure to electrical risk in the electrical termination block is located immediately behind the rms waste container.
  • 조치
    Care should be taken when removing the waste container from the RMS module. Under no circumstances should you place your hands in the RMS cabinet beyond what is necessary to remove the waste container. If any flex cartridge drops out of the waste container, do not enter the RMS cabinet to remove it. In addition, the WARNING page posted within the Warning Message should be attached on the outside of each RMS cabinet the customer owns, serving as a temporary warning to all operators until the machines are inspected. Please note that only customers who own the RMS module (optional) will be subject to the field action. (Code DI 16-01)

Device

SYSTEM DIMENSION EXL - Registration nº 10345161695. Serial Numbers: 12251428; 12252714.

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnóstics Inc.