Events

Device Recall Model Kodak 2200 Intraoral XRay System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carestream Health 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
    67349
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1128-2014
  • 사례 시작날짜
    2014-01-24
  • 사례 출판 날짜
    2014-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125304
  • 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
    Unit, x-ray, extraoral with timer - Product Code EHD
  • 원인
    Carestream received problem reports relating to apparent early failure of kodak 2x00 intraoral x-ray device arms leading to arm breakage.
  • 조치
    Urgent Medical Device Recall Letters (dated 1/24/2014) were sent to the consignees on 1/24/2014 via Certified Mail, Return Receipt Requested.

Device

Device Recall Model Kodak 2200 Intraoral XRay System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. USA (nationwide) and the country of Canada.
  • 제품 설명
    Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- || --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
  • Manufacturer
    Carestream Health Inc.

Manufacturer

Carestream Health Inc.
  • 제조사 주소
    Carestream Health Inc., 150 Verona St, Rochester NY 14608-1733
  • 제조사 모회사 (2017)
    ONEX Corp
  • Source
    USFDA