Events

Device Recall Retcam3 & Retcam Shuttle with version 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Clarity Medical Systems 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
    61180
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1099-2012
  • 사례 시작날짜
    2012-02-02
  • 사례 출판 날짜
    2012-02-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107470
  • 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
    Camera, ophthalmic, Ac-powered - Product Code HKI
  • 원인
    Still images extracted from video recordings may be mislabeled as to right and left eye.
  • 조치
    Clarity Medical Systems, Inc. sent a Safety Alert letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following : 1. Do not use the video mode until the software has been updated. 2. Install the software update using the enclosed CD. The instructions for installation are also enclosed. This software update will correct the anomaly. 3. If you have extracted still images from video recordings, review all potentially affected patient files to determine if any right eye images are mislabeled as left eye images and/or left eye images are mislabeled as right eye images. If any images are mislabeled, make the appropriate corrections in the annotation section of the affected file. Consider whether there is any diagnostic impact or need to re-irnage the patient. We apologize for the inconvenience. If you have questions or concerns, please contact Clarity at 800-215-6005.

Device

Device Recall Retcam3 & Retcam Shuttle with version
  • 모델명 / 제조번호(시리얼번호)
    Model number RC3, part number 21-100500; Model number RCS, part number 20-000300.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of TN, MO, TX, FL, NJ and Puerto Rico and countries of Italy, Portugal, Czech Republic, Thailand, Chile, Oman, Hong Kong, Russia, Philippines, Sweden, Finland, Ecuador, Australia and Canada.
  • 제품 설명
    Retcam3 & Retcam Shuttle with version 6.0 software. || Clarity Medical Systems, Inc. || 5775 W. Las Positas Blvd, Suite 200 || Pleasanton, CA 94588 || General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
  • Manufacturer
    Clarity Medical Systems Inc

Manufacturer

Clarity Medical Systems Inc
  • 제조사 주소
    Clarity Medical Systems Inc, 5775 W Las Positas Blvd, Pleasanton CA 94588
  • 제조사 모회사 (2017)
    Natus Medical Incorporated
  • Source
    USFDA