Magnetic Resonance Imaging Systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 GE Medical Systems 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
  • 날짜
    2015-01-08
  • 사례 출판 날짜
    2015-01-08
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: ge medical systems magnetic resonance imaging systems health canada posted a medical device safety alert concerning various magnetic resonance imaging (mri) systems, manufactured by ge medical systems. the affected devices are identified as follow:- msk extreme - mri system optima mr430s 1.5t - mri system signa hde 1.5t mri system discovery mr750w 3.0t mri system 1.5t signa horizon mri system signa 1.5t excite hd magne - mri system 3.0t signa hdx mri system 1.5t signa hdx mri system discovery mr750 mri system 1.5t signa infinity twinspeed with excite mri syst signa 1.5t infinity excite mri system signa hdxt 1.5t mri system discovery mr450 1.5t mri system signa hdi 1.5 t mri system -16 channel mobile optima mr450w -16ch mri system optima mr450w -32ch mri system optima mr450w -gem mri system optima mr360 main unit in the affected devices, magnet rundown unit (mru) may not be connected to the magnet. if the mru is disconnected, the mru will not function as expected and will not quench the magnet when the button is pressed. in emergency situations, a disconnected mru could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times. for details, please refer to the following health canada websites: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43153r-eng.Php http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43157r-eng.Php http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43103r-eng.Php http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43165r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 january 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: GE Medical Systems Magnetic Resonance Imaging Systems
  • Manufacturer

Manufacturer