OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carl Zeiss 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-2014-RN-00174-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-20
  • 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
    Based on post-market surveillance of hardware system performance, it has been identified that system components may cause, in rare situations, a blocking of the magnetic brakes or a system freeze/ system restart during operation potentially prolonging surgery.
  • 조치
    Carl Zeiss is providing a software and hardware update to ensure the malfunction does not occur. An enhanced long-term software and hardware maintenance of the OPMI Pentero system procedure is also included in the maintenance package. This action has been closed-out on 28/01/2016

Device

  • 모델명 / 제조번호(시리얼번호)
    OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010Serial Numbers: 6631402471 to 6631461774ARTG Number: 187127
  • Manufacturer

Manufacturer