Events

Helix - All configurations - Product with more than 20 years of manufacture 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médicos-Hospitalares Ltda. 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
    1461
  • 날짜
    2014-04-09
  • 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 reports that life-threatening potential may occur if there is unintended movement of the radial detector, leading to contact with the patient. ////// Update - 07/10/2014 - The company informs that 9 clients received the letter referring to this field action, giving notice of the interruption of the use of the equipment. It was verified that the system with identification 0252A was deactivated.
  • 원인
    The company ge healthcare of brazil reported that during a whole body scan, the detector can move to the initial position, and then slowly starting the internal movement towards the patient. this movement will generate both a visual and audio alert condition on the console and the gantry. this mode of failure was observed in a single system.
  • 조치
    The company directs users to immediately stop using this system and confirm by letter that the system has been withdrawn from service. Due to the date of manufacture and the life cycle of the Helix product, the user will already have received a letter from GE Healthcare in 2008 stating that the product was at the end of its useful life, that GE would no longer issue service contracts for these systems and that there would be no more spare parts support. You should confirm that you have disabled the system by completing the enclosed Customer Response Form. If the user wants help with the removal and disposal of their Helix system, GE Healthcare will do so at no cost.

Device

Helix - All configurations - Product with more than 20 years of manufacture

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médicos-Hospitalares Ltda.