Events

Magnetic Resonance Imaging Equipment Optima and Discovery; Records and Models: 80071260118 - Optima MR450W; 80071260300 - Optima MR450W and Optima MR450W and GEM; 80071260134 Discovery MR750W 3.0T; 80071260116 - Discovery MR450. Risk class II, containing the table option: MR Surgical Suite II with model numbers: M8074SS, M8053SS and M0074SS. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil, Com. e Serv.; GE MEDICAL SYSTEMS LLC. 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
    1712
  • 날짜
    2015-10-07
  • 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
    According to the manufacturer, the unexpected loss of function of the patient transfer mechanism may prevent the transfer of the patient from the MRI table to the surgical table. In this way, the occurrence of this failure can generate delays in the care and treatment of patients during surgical or interventional procedures.
  • 원인
    Unexpected loss of the function of the patient transfer mechanism that allows the patient to be transferred from the mri table to the surgical table. a complaint was made regarding the non-release of the transfer board from the table of resonance preventing the movement of the board towards the surgical table.
  • 조치
    Parts / parts correction. The table can still be used. However, they should be aware of any problems related to the release of the table. If any failure is observed, a GE field engineer should be contacted to correct the problem. Action code: IMF 60885.

Device

Magnetic Resonance Imaging Equipment Optima and Discovery; Records and Models: 80071260118 - Opti...

Manufacturer

GE Healthcare do Brasil, Com. e Serv.; GE MEDICAL SYSTEMS LLC.