Events

Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AMO Australia 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-2013-RN-01093-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01093-1
  • 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
    The manufacturer is aware of an issue that has the potential to result in loss of illumination due to unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to overheating of a specific component found in a limited amount of star system, which can result in a burning smell coming from the laser system.
  • 조치
    Abbott Medical Optics (AMO Australia) is advising users that the printed circuit board of the affected units will be replaced prior to 31 January 2014. AMO is advising users to contact the AMO service representative in the case a system has a loss of illumination.

Device

Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)
  • 모델명 / 제조번호(시리얼번호)
    Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)Model Number: S4 IRSerial Number: 9271ARTG Number: 120575
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd