Events

Device Recall Cirrus HDOCT Model 4000 instruments 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carl Zeiss Meditec 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
    58313
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2127-2011
  • 사례 시작날짜
    2011-03-10
  • 사례 출판 날짜
    2011-05-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99272
  • 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
    Tomography, optical coherence - Product Code OBO
  • 원인
    A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient.
  • 조치
    Carl Zeiss Meditec, Inc. sent an Field Correction Action letter dated March 9, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letters requested acknowledgement of the letter and a response and the fact that a follow up packet with revised software will be sent to all customers with V 5.0.0 or 5.1.0 software. For questions, please call 1-855-853-9461.

Device

Device Recall Cirrus HDOCT Model 4000 instruments
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Boliva, Brazil, Canada, France, Chili, China, Columbia, Denmark, Ecuador,Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Japan, Lebanon, Malaysia, Mexico, New Zealand, Pakistan, Peru, Singapore,South Korea, Spain, Sri Lanka, Taiwan, Uruguay and Venezuela
  • 제품 설명
    Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0 || The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.
  • Manufacturer
    Carl Zeiss Meditec Inc

Manufacturer

Carl Zeiss Meditec Inc
  • 제조사 주소
    Carl Zeiss Meditec Inc, 5160 Hacienda Dr, Dublin CA 94568
  • 제조사 모회사 (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA