Alcon LuxOR LX3 Microscope Floor Stand(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 175mm and 200mm) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Alcon Laboratories 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-2017-RN-00727-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-02
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Alcon has observed that multiple shipments or forceful impact to a caster on a luxor lx3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base. during an in-facility transfer, should a caster break or detach from the base while the microscope arm is not in the most inward locked position, the unit may tip if the microscope arm is extended over the location of the broken caster. this may lead to the potential for physical injury from the microscope tipping or falling.To date, two incidents of physical injury have been reported overseas in conjunction with this issue.
  • 조치
    Alcon will contact users to schedule an appointment to inspect and retrofit LuxOR LX3 units with new bases and/or an updated caster configuration. In the interim, users are advised to ensure the articulating microscope arm is placed in a stowed and locked position over the microscope base and protect the casters from forceful impact. (Refer to recall notification for further details). Users are to contact their Alcon technical representative if they need to transport their unit to an off-site location or have immediate concerns about their unit.

Device

  • 모델명 / 제조번호(시리얼번호)
    Alcon LuxOR LX3 Microscope Floor Stand(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 175mm and 200mm)Catalogue Number: 8065752560ARTG Number: 210550
  • Manufacturer

Manufacturer