Events

Device Recall Leica M525 OH4 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leica Microsystems (Schweiz) Ag 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
    64601
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2176-2013
  • 사례 시작날짜
    2012-12-18
  • 사례 출판 날짜
    2013-09-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116798
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Microscope, surgical, general & plastic surgery - Product Code FSO
  • 원인
    The brake in the z axis and/or brakes in the ab and c axes failed during installation.
  • 조치
    The firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at LMGRA@leica-microsystems.com or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.

Device

Device Recall Leica M525 OH4
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: OH4-84712,  OH4-84812,  OH4-84912
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.
  • 제품 설명
    Surgical microscope || The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
  • Manufacturer
    Leica Microsystems (Schweiz) Ag

Manufacturer

Leica Microsystems (Schweiz) Ag
  • 제조사 주소
    Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny-Strasse, Heerbrugg Switzerland
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA