Events

VisuMax Laser 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-2017-RN-00318-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00318-1
  • 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
    Based on complaints, carl zeiss has identified that in certain devices there is an increased probability of failure of the battery test circuit components of the uninterrupted power supply (ups)-module. it was reported from customers that after treatment was done and machine was switched off white smoke with choking smell came out from the ups at the rear side of the machine. there were no patient involvement and no adverse consequences associated with these complaints.
  • 조치
    The battery circuit for the UPS has been modified to make the UPS more robust. Carl Zeiss will replace all old power supplies as part of the next scheduled service activities of the VisuMax.

Device

VisuMax Laser
  • 모델명 / 제조번호(시리얼번호)
    VisuMax LaserSerial numbers starting with 963599 up to 1157772ARTG Number: 150527
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd