Events

Slit Lamp 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-01150-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-09-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01150-1
  • 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 post market surveillance activities, carl zeiss has determined that in certain devices there is an increased probability of failure of the power supply on/off switch, and surface corrosion of the mirror which changes the direction of the light projection. there is no potential health hazard and the probability of injury is extremely unlikely. in a worst case scenario, a burning smell may result from a thermal event at the power supply on/off switch. issues associated with the surface corrosion of the mirror may lead to inadequate mirror function. the slit projection may be slightly darker and more diffused.
  • 조치
    Replace the affected power supply and mirror. Carl Zeiss service staff will arrange an appointment for the replacement of the power supply and the mirror of your slit lamp SL 220.

Device

Slit Lamp
  • 모델명 / 제조번호(시리얼번호)
    Slit LampModel Number: SL 220 Serial Numbers: 970712XXXX and 970714XXXXARTG Number: 94353
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd