Device Recall multiple Laser Scanning Microscopes. 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
    80115
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2058-2018
  • 사례 시작날짜
    2018-05-08
  • 사례 출판 날짜
    2018-06-09
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Spectroscopy instrument - Product Code REM
  • 원인
    In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the class i limit.
  • 조치
    1.Your firm will send an initial email to all known users advising them of the issue, the risk involved and associated mitigations until the units can be evaluated by Carl Zeiss service representatives, 2.Your firm will send a second written communication to each first line purchaser and to each known user site with the notice of action and warning to discontinue use of the component until it has been verified as defective or properly functioning, and 3.Your firm will dispatch factory trained service representatives to perform verification tests and to replace defective units as necessary, free of charge. CDRH approves the CAP subject to the following conditions: For further questions, please call (914) 747-1800.. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Corrective actions will be provided at no cost to the purchasers and completed by March 1, 2019.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    USA (nationwide)
  • 제품 설명
    Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple || Laser Scanning Microscopes. || Laser scanning microscopes are used in cell biology research.
  • Manufacturer

Manufacturer

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