Device Recall Compensator Slider Lambda 6x20 component 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zeiss, Carl Inc 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
    67178
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0799-2014
  • 사례 시작날짜
    2013-12-20
  • 사례 출판 날짜
    2014-01-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-04-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Light, microscope - Product Code IBJ
  • 원인
    Carl zeiss microscopy, llc has recalled the compensator slider lamda 6x20 component utilized on standard pathology microscopes due to misalignment of the lambda plate.
  • 조치
    Carl Zeiss, Inc. sent an Important Medical Device Corrective Action letter dated December 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that their service provider would contact them to schedule a visit in which a factory trained service technician would install a new Compensator Slider Lambida 6x20. Customers should return the old Compensator Slider to the factory for testing. Customers with technical questions were instructed to call 914-681-7815.

Device

  • 모델명 / 제조번호(시리얼번호)
    part number 473704-0000-000
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.
  • 제품 설명
    Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). || Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zeiss, Carl Inc, 1 Zeiss Dr, Thornwood NY 10594-1939
  • 제조사 모회사 (2017)
  • Source
    USFDA