Sterrad NX Sterilizer 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Advanced Sterilization Products 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
    2015-10-02
  • 사례 출판 날짜
    2015-10-02
  • 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: advanced sterilization products sterrad nx sterilizer medical device manufacturer, advanced sterilization products (asp), has issued a medical device safety alert concerning its sterrad nx sterilizer [part number: 10033]. the manufacturer has recently identified that the sterrad nx sterilization system may exceed the radiated emissions international standard limit by 20 decibel micro-volt per meter (dbμv/m), which equates to 0.001 volt per meter (v/m) at a distance of 10 meters. based on the manufacturer’s analysis, the risk is low for interference to active implantable and wearable devices and other nearby electrical equipment. there is no health consequences anticipated on the issue. the manufacturer advises affected users to continue to take the precautions normally exercised for adjacency of sterrad nx sterilization system with other electromechanical equipment and electronic medical devices. the manufacturer will begin the process of correcting systems to reduce the emissions to meet the international standard limit within the next 90 days. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Advanced Sterilization Products Sterrad NX Sterilizer
  • Manufacturer

Manufacturer