Events

Abbott Medical Optics (AMO) STAR Excimer Laser System 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-00567-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00567-1
  • 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
    There is the potential for an inadvertent laser firing with no surgeon interaction on the foot pedal due to incorrect output of electrical foot switch buffer when the following conditions are present:1- circuit breaker c9 is tripped open, causing a remote panel pcb power loss2- normal system interlocks are cleared (system waiting for surgeon intervention)there have been no reports of inadvertent firing of the laser in the field.
  • 조치
    Abbott Medical Optics is replacing the circuit board component of all STAR Excimer Laser Systems. The manufacturer has advised that the devices may continue to be used to treat patients. In the unlikely event that the system initiates treatment without direct input, physicians are advised to immediately use the Laser Stop Button located on the doctor's panel as described in the Operators Manual.

Device

Abbott Medical Optics (AMO) STAR Excimer Laser System
  • 모델명 / 제조번호(시리얼번호)
    Abbott Medical Optics (AMO) STAR Excimer Laser SystemModels: S3, S4 and S4 IR
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd