NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Healthcare 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-00502-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-12
  • 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
    Ndi determined that drms spheres from lot c102061501 may break apart at the mid-point where the two halves of the sphere are sealedtogether, either during installation onto reference arrays or surgical tools (i.E., when threading them onto posts), or any time during a surgical procedure.One failure of this nature has been reported, with no report of injury or death.
  • 조치
    Life Healthcare is requesting their customers to quarantine any affected stock. Life Healthcare will provide replacement stock where required. This action has been closed-out on 10/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems)Lot C102061501ARTG Number: 182255
  • Manufacturer

Manufacturer