Events

Anvisa nº 80071260008, series 79 - C1841 and 79-C1903, manufactured by GE Healhcare OEC Medical Systems in Germany and marketed in Brazil by GE Healthcare do Brasil Trade and Services for Medical- Hospitalares Ltda. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healhcare OEC Medical Systems; GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico-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
    916
  • 날짜
    2008-05-08
  • 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
    For more information, contact the Customer Service Center on 0800 122 345.
  • 원인
    The system design may compromise the first barrier located at the rear of the camera, causing unexpected exposure of the operator and / or his or her personnel within the radius of the equipment. this problem may even cause the system to initial non-conformance according to the provision for radiation leakage barrier (21 cfr 1020.32 (a).) ge informs that this radiation exposure has minimal impact, operator, team or patient and that it can not cause any major radioactive damage. the manufacturer issued an electronic product radiation warning letter, available at the link: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/ alerta_916_carta.Pdf the alert published by ecri, translated into portuguese, is available at http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/alerta_916_traduz.Pdf.
  • 조치
    Identify any affected products in your inventory and verify that you received the Electronic Product Radiation Warning Letter dated February 14, 2008. GE does not recommend that affected devices be removed from the service. GE is working on a solution to the problem. As soon as the solution is made available, the GE representative will contact your customers for free assistance.

Device

Anvisa nº 80071260008, series 79 - C1841 and 79-C1903, manufactured by GE Healhcare OEC Medical S...

Manufacturer

GE Healhcare OEC Medical Systems; GE Healthcare do Brasil Comércio e Serviços para Equipamentos M...