Events

X-ray Mobile Device X-ray Mobile Device Registration Number ANVISA: 80071260301 Hazard Class: III Model Affected: Brivo OEC 715, Brivo OEC 785, Brivo OEC 865 Affected serial numbers: • GE Brivo OEC715: Series numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051; • GE Brivo OEC785: Series numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152; • GE Brivo OEC865: Series numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029 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 Médico-Hospitalares Ltda.; GE Hualun Medical Systems CO., LTD / GE Healthcare do Brasil, Com. e Serv. 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
    2142
  • 날짜
    2016-10-04
  • 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
    Before starting the procedure, the operator must check that the C-arc moves up and down normally, and that the emergency stop button is working correctly. If the C-arc moves up or down without a command, during a procedure, the user must press the emergency stop button to prevent the C-arc from colliding with medical instruments. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • 원인
    The plate that controls the vertical movement of the c-arc can fail and result in c-arc movement up or down, without command. there were no injuries reported as a result of this problem. however, this problem can cause soft tissue damage if the c-bow moves down during a surgical procedure and collides with the medical instruments.
  • 조치
    Field Action IMF Code 15132 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will make correction in the field.

Device

X-ray Mobile Device X-ray Mobile Device Registration Number ANVISA: 80071260301 Hazard Class: III...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Hualun Medi...