Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Brainlab Australia 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-2015-RN-00396-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-12
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Brainlab navigation software offers automatic registration of ct image data sets, intraoperatively acquired with an integrated neurologica bodytom portable ct scanner (“bodytom”). in the course of clinical usage of these devices at different hospitals, registration inaccuracies have been identified in some instances when using automatic registration with bodytom. in these cases the data set could not be accurately registered to the actual patient anatomy when performing automatic registration. an accurate registration (match between ct image data set virtually displayed in navigation and the current patient anatomy) is essential for a successful navigation.If a potentially inappropriate registration is not detected during user verification, the deviation of the position information in the navigation software could mislead the user regarding clinical decisions. this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
  • 조치
    To reduce the risk of an inappropriate automatic registration, Brainlab in cooperation with NeuroLogica has developed an improved integration and verification workflow to be followed by users which is provided with the customer letter. Brainlab will individually contact each affected customer to offer: a) a service visit to assist in the selection and marking of a suitable movement path and to perform the calibration and verification in cooperation with Neurologica. b) an additional training regarding the improved verification methods. This action has been closed-out on 08/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1 ARTG Number: 96517
  • Manufacturer

Manufacturer