Events

Stellaris PC with Laser System (Cataract extraction/vitrectomy system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bausch & Lomb 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-2014-RN-01205-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01205-1
  • 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 stellaris pc has a software fault, when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo to endo continuous) and the system is in “standby”, the system will automatically transition from “standby” to “ready” to fire. if the system moves to ready from standby, and this has not been specifically commanded by the surgeon or the nurse, it raises the possibility that this change may not have been noticed and that the foot pedal could be depressed and the laser may fire unexpectedly.
  • 조치
    Bausch and Lomb has developed a software update to address the situation, which will be installed in the affected system. In the meantime, users may continue to use the Stellaris PC laser system. However, they are advised not to request the Laser sub-mode change from Endo to Endo Continuous during surgery until the software update has been implemented. This action has been closed-out on 06/06/2016.

Device

Stellaris PC with Laser System (Cataract extraction/vitrectomy system)
  • 모델명 / 제조번호(시리얼번호)
    Stellaris PC with Laser System (Cataract extraction/vitrectomy system)Product Code: BL14304Serial Number : SPC02059ARTG Number: 127264
  • Manufacturer
    Bausch & Lomb Australia Pty Ltd

Manufacturer

Bausch & Lomb Australia Pty Ltd