Events

Medtronic Navigation Framelink (used with Medtronic Navigation StealthStation S7 and i7 systems or a Medtronic Planning Station for image guided surgery) Software version 5.4 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-00722-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00722-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Medtronic has identified that the use of high resolution exams (greater than 256 x 256) under certain use 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, visualisation of the planned trajectory could show the image at the incorrect depth. further internal investigation of similar or related views discovered that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause a similar discrepancy between the exam image and the displayed measurement or overlay. the use conditions are;- use of framelink 5.4 software on an s7, i7 or planning station system that has a rollingstone computer, and- the framelink 5.4 software configuration setting "use fillslicestackresolution" is set to true, and- the user loads a high-resolution exam for use during a surgical procedure.
  • 조치
    Medtronic is requesting users to not use high-resolution examinations (greater than 256 x 256). A software solution will be implemented to permanently correct the issue.

Device

Medtronic Navigation Framelink (used with Medtronic Navigation StealthStation S7 and i7 systems o...
  • 모델명 / 제조번호(시리얼번호)
    Medtronic Navigation Framelink (used with Medtronic Navigation StealthStation S7 and i7 systems or a Medtronic Planning Station for image guided surgery)Software version 5.4Product Number: 9734047All lot numbers of version 5.4 affectedARTG Number: 126293
  • 의료기기 분류등급
    Neurological Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA