Events

X-ray system mobile arches in C 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-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
    I1610-441
  • 사례 연번
    2009EBC-0003260
  • 날짜
    2016-10-25
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=117
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that if before or during a procedure, the c-arm moves up or down without pressing, it must press the emergency stop button and suspend the use of the equipment, this failure would lead to potential serious adverse events being presented. the patients or users.

Device

X-ray system mobile arches in C
  • 모델명 / 제조번호(시리얼번호)
    BRIVO OEC 715, BRIVO OEC 785 and BRIVO OEC 865, specific serials.
  • 제품 설명
    X-ray systems or "mobile arcs in C" are general-purpose diagnostic equipment, with mobility around the operation or examination table, based on x-ray technology that allows: obtaining and / or recording of fixed images (conventional radiography and digital) of internal body structures by exposing a part of the body to a small dose of x-ray radiation; obtaining and / or recording moving images in real time (continuous, pulse or snapshot fluoroscopy) and taking video of the patient's internal structures as support for diagnostic, surgical procedures and intervention procedures. These equipments are designed to visualize anatomical structures converting a radiation pattern x into a visible image through electronic amplification. Clinical applications include, but are not limited to, the following: cholangiography, endoscopy, urology, orthopedics, vascular and cardiac neurology including implantation of heart rate management devices, calculus localization, thoracic surgery, gastrointestinal tract investigations, vessel angiography of legs, heart and brain, and can be used for other imaging applications at the doctor's discretion.
  • Manufacturer
    GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda

Manufacturer

GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE...