Events

magnetic resonance equipment 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 General Medical Merate Spa || GE Healthcare || GE Medical Systems Scs || GE Medical Systems Technologies Co Ltd || GE Medical Systems Information Technologies Gmbh || GE Medical Systems, Llc. || Xinaomdt Technology Co, Ltd || GEHangwei Medical Systems Co. Ltd || GE Medical Systems, Llc (Dba Ge Healthcare), || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda || GE Healthcare (Tianjin) Company Limited 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
    I1609-396
  • 사례 연번
    2007DM-0001028
  • 날짜
    2016-09-23
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=121
  • 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 the output power of the rf amplifier is higher than the specific absorption rate (sar: specific absorption rate), the rf power monitor interrupts the acquisition, if the user performs a tps reset (treatment and storage of the transceiver) for the acquisition of a patient, the rf power monitor is turned off during the rest of the test for this patient, being unable to detect an abnormality of the higher rf transmission function, causing heating and localized doses higher than expected leading to may present potential serious adverse events to patients.

Device

magnetic resonance equipment

Manufacturer

General Medical Merate Spa || GE Healthcare || GE Medical Systems Scs || GE Medical Systems Techn...
  • Source
    NIDFSINVIMA