Events

Equipment For Angiography, Image Guided System, Model INNOVA IGS 530, Hazard Class III, Record: 80071260269, serial number of the affected unit: XV650620BU8. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil; GE MEDICAL SYSTEM S.C.S. 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
    1604
  • 날짜
    2015-06-07
  • 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 company, if the Gantry Motion Control Board (MCB) fails, limiting the movement of the fluoroscope may interfere, complicate or prolong any interventional procedure that is dependent on multiple fields of view , affecting the diagnostic and therapeutic accuracy of the image. The ability to perform imaging and diagnostics can also be impaired.
  • 원인
    Safety problem related to the loss of the ability to move the arm gantry in c (c-arm) in the system of interventional imaging of fluoroscopy. loss of gantry movement capacity is caused by a failure in the gantry motion control board (mcb). after system reboot, x-rays and manual movements of the gantry and table shafts will be available.
  • 조치
    The company will make a field correction of the affected equipment. The user can continue to use the system, avoiding abrupt changes of direction with the movements of the gantry and preventing potential collisions with other equipment. If failure occurs during an interventional examination / procedure, the user should ensure that he / she has the procedures in place to handle patients in the event of loss of gantry movement as described on the labeling of their product.

Device

Equipment For Angiography, Image Guided System, Model INNOVA IGS 530, Hazard Class III, Record: 8...

Manufacturer

GE Healthcare do Brasil; GE MEDICAL SYSTEM S.C.S.