Events

Device Recall Gendex CB500 3D Dental Imaging System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Imaging Sciences International, LLC 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
    51424
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1265-2009
  • 사례 시작날짜
    2009-01-08
  • 사례 출판 날짜
    2009-05-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80255
  • 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
    System,x-ray,extraoral source,digital - Product Code MUH
  • 원인
    Faulty calibration.
  • 조치
    Imaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed "Acknowledgement Form" by fax to the firm at 1-215-997-5665. Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299.

Device

Device Recall Gendex CB500 3D Dental Imaging System
  • 모델명 / 제조번호(시리얼번호)
    Model number: G1-15-1-0; Serial Numbers: NU010261, NU010340, NU010224, NU010286, NU010265, NU010267, NU010282, NU010283, NU010284, NU010287, NU010288, NU010289, NU010292, NU010293, NU010294, NU010299, NU010303, NU010310, NU010315, NU010316, NU010317, NU010326, NU010290, and NU010291.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
  • 제품 설명
    Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
  • Manufacturer
    Imaging Sciences International, LLC

Manufacturer

Imaging Sciences International, LLC
  • 제조사 주소
    Imaging Sciences International, LLC, 1910 North Penn Rd, Hatfield PA 19440-1960
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA