Leica ASP200S & Leica ASP300S. In vitro diagnostic medical devices (IVD)(Histology sample processing instruments) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Microsystems 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-00717-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-05
  • 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
    Leica microsystems recently became aware that affected devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure. the missing alarm signal could lead to suboptimal quality tissue processing. in some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.
  • 조치
    A Leica Service Engineer will correct the internal wiring and check the remote alarm functionality.

Device

  • 모델명 / 제조번호(시리얼번호)
    Leica ASP200S & Leica ASP300S. In vitro diagnostic medical devices (IVD)(Histology sample processing instruments)Leica ASP200S Product Code: 14048043625Serial Numbers: 5329, 5448, 5528, 5707Leica ASP300SProduct Code: 14047643514Serial Numbers: 5361, 5639, 5721, 5872, 6057
  • Manufacturer

Manufacturer