Events

iPlan CMF 3.0, iPlan Cranial 3.0, iPlan ENT 3.0, iPlan Flow 3.0, iPlan spine 3.0, iPlan Stereotaxy 3.0 (including all subversions) 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-2013-RN-00687-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00687-1
  • 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
    When exporting a treatment plan created with brainlab iplan 3.0 for usage with brainlab navigation software, planned objects may be shown cropped, boundaries shaped differently or the objects may appear larger or smaller if all of the following conditions are met:1. the plan is exported to one of the following navigation software (standard brainlab format is used):-vectorvision cranial/ent ver. 7.X; -kolibri cranial/ent ver. 2.X; -cranial/ent essential/unlimited ver. 1.X; -vectorvision spine ver. 5.5.1; -vectorvision spine ver. 5.6.2. one or more slices of the image set (or any of the image sets fused to it) exceeds a coordinate of +511mm or -511mm, and the contours of the planned object extend into those slices.3. the standard export settings have been changed: the feature "enable interpolation for non-512x512 images" is disabled.
  • 조치
    Brainlab are providing users with work around instructions to mitigate the risks as an interim measure. A software update will be provided in users when available to permanently correct the issue. This action has been closed-out on 28/01/2016.

Device

iPlan CMF 3.0, iPlan Cranial 3.0, iPlan ENT 3.0, iPlan Flow 3.0, iPlan spine 3.0, iPlan Stereotax...
  • 모델명 / 제조번호(시리얼번호)
    iPlan CMF 3.0, iPlan Cranial 3.0, iPlan ENT 3.0, iPlan Flow 3.0, iPlan spine 3.0, iPlan Stereotaxy 3.0 (including all subversions)ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd