Events

Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic Navigation 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
    2013-07-19
  • 사례 출판 날짜
    2013-07-19
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130719.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
    Medical device safety alert: medtronic navigation stealthstation s7 and i7 systems and planning station containing framelink software version 5.4 medical device manufacturer, medtronic navigation, inc. issued a medical device safety alert concerning navigation stealthstation s7 and i7 systems and planning station containing framelink software version 5.4. the following part numbers are affected: 9734047 (framelink s7 applications kit) 9734066 (framelink s7 planning station kit) 9733986 (framelink application software) medtronic has identified that the use of high resolution exams (greater than 256 x 256) under certain conditions may cause the look-ahead view labels to show user selected depths (displayed), but the corresponding images are shown at a depth twice the selected distance. under these conditions, visualization of the planned trajectory could show the image at the incorrect depth. medtronic has received three customer reports related to this issue. none of the reports cited any patient injuries or adverse events. according to the manufacturer, the framelink software version 5.4 has been revised to correct the software anomalies mentioned above. until the software upgrade has been installed, users are advised not to use high resolution examinations (greater than 256 x 256). if users are not sure of the exam resolution being used, they should contact the local supplier for assistance. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2013.

Device

Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Ve...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4
  • Manufacturer
    Medtronic Navigation

Manufacturer

Medtronic Navigation
  • 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