Events

ManoShield™ AR 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Sierra Scientific Instruments 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
    2011-12-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111228.html
  • 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
    Field safety notice: sierra scientific instruments manoshield™ ar medical device manufacturer, sierra scientific instruments, is conducting a product recall for manoshield™ ar, part number mss-3599. the lot numbers affected are listed below: lot number f1114619ua f1114625ua f1115402ua f1123703ua f1128101ua f1114620ua f1114626ua f1121304ua f1124202ua f1129701ua f1114621ua f1114627ua f1123405ua f1125201ua f1130202ua the recall is initiated because of quality defects found on some lots of the products. the, defects occurred during normal use, and were noted when product was used in a manner that was not supported by its design specification and tolerances. according to the local supplier, products with the affected lot numbers have not been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

ManoShield™ AR
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Sierra Scientific Instruments ManoShield™ AR
  • Manufacturer
    Sierra Scientific Instruments

Manufacturer

Sierra Scientific Instruments
  • 제조사 모회사 (2017)
    Medtronic Plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH