Device Recall Endophotocoagulation Delivery 4EP1 of GYC1000 Green Laser Photocoagulator System; 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nidek 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
    71527
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2068-2015
  • 사례 시작날짜
    2015-03-25
  • 사례 출판 날짜
    2015-07-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-07-14
  • 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
    Powered laser surgical instrument - Product Code GEX
  • 원인
    Accessories to the gyc-1000 laser were missing laser aperture labels.
  • 조치
    Nidek sent Recall Notifications to doctors on March 31, 2015, by Federal Express. Letters were specific to the accessory involved. NIDEK detected that the laser aperture label has not been affixed on the delivery unit of GYC-1000, Green Laser Photocoagulator System and the device does not meet FDA regulation 21 CFR Subchapter J. In order to comply with FDA regulation, Nidek requests that the customer affix the enclosed laser aperture label to the Dual Delivery 4DD-1 of GYC-1000, according to the instructions attached. Please see the enclosed Laser Aperture label, instruction for affixing to the device and the response card. Nidek requests that you complete and return the response card as soon as possible. For additional information, please call Nidek at 1-800-223-9044 or visit http://usa.nidek.com

Device

  • 모델명 / 제조번호(시리얼번호)
    Model GYC4EP-01 0W02 and GYC4EP-1 0Z20;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
  • 제품 설명
    Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; || GYC4EP-01 0W02 and GYC4EP-1 0Z20; || The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • 제조사 모회사 (2017)
  • Source
    USFDA