Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Microsystems 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-00935-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-06
  • 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
    Leica microsystems is notifying their customers of an important safety issue concerning the ceiling supply units csu 80xx/ csu 60xx, manufactured from 1997 - 2003. the ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approximately 60 cm (23.6 inches).
  • 조치
    Leica Microsystems is contacting their customers to arrange for the complete inspection of the ceiling mount and is providing customers with additional preventative maintenance protocols.

Device

  • 모델명 / 제조번호(시리얼번호)
    Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)Leica Ceiling Mount MSF-1Art. Numbers: 10446781 & 10446782Leica Ceiling Mount MS-1F & MC-1FArt. Numbers: 10446657 & 10446658ARTG Number: 137683
  • Manufacturer

Manufacturer