Events

Device Recall Kodak DirectView DR 7500 Diagnostic 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
    68727
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2177-2014
  • 사례 시작날짜
    2014-07-09
  • 사례 출판 날짜
    2014-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128573
  • 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, stationary - Product Code KPR
  • 원인
    An on-site evaluation of the equipment parts that attach the beta assembly (x-ray tube and collimator) to the over head tube crane (otc) telescope was completed by carestream health (csh) service engineering. inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the beta assembly detached from the otc telescope, the lock nut was not sufficiently tightened.
  • 조치
    Carestream will notify all DR 7500 customers of the issue and schedule a Field Engineer to inspect and repair the system if required. Specific instructions (Service Modification) for the inspection and repair will followed by the Carestream Field Engineer in order to complete the correction. Documented evidence of the Field Engineer visit will be noted in the Carestream service engineering record for each affected system. Carestream estimates that the plan of correction will be completed within 2-4 weeks

Device

Device Recall Kodak DirectView DR 7500 Diagnostic XRay System
  • 모델명 / 제조번호(시리얼번호)
    The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
  • 제품 설명
    Kodak DirectView DR 7500 Diagnostic X-Ray System || Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • 제조사 주소
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • 제조사 모회사 (2017)
    ONEX Corp
  • Source
    USFDA