Mass Spectrometry Instruments 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Waters Corporation 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
    2012-10-24
  • 사례 출판 날짜
    2012-10-24
  • 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: waters corporation mass spectrometry instruments medical device manufacturer, waters corporation, has initiated a medical device field safety corrective action concerning various models of mass spectrometry instruments. the affected models can be identified as follows:- waters acquity tqd; acquity sqd; lct premier xe; quattro premier; quattro premier xe; quattro micro; xevo g2 tof; xevo tq; xevo tqd & zq 2000 the manufacturer initiated this voluntary medical device correction because there is a possibility that the ion block source heater may fail. in some instances, the failure could cause a short term loss of or variation in sensitivity that may subsequently lead to inaccurate data. the loss of or variation in sensitivity is most pronounced in assays with shorter dwell times (i.E. less than 100 ms) and may not always be detected by quality control and internal standard value monitoring. no adverse events have been reported as a result of this potential issue. according to the manufacturer, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Waters Corporation Mass Spectrometry Instruments
  • Manufacturer

Manufacturer