Events

Device Recall Carestream Health DRXRevolution Mobile 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
    69826
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0800-2015
  • 사례 시작날짜
    2014-11-25
  • 사례 출판 날짜
    2014-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131774
  • 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, mobile - Product Code IZL
  • 원인
    While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. carestream has identified an issue related to the drx-revolution mobile x-ray system in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. it has been determined that this issue is a result of an improperly assembled part which holds the x-ray.
  • 조치
    The firm, Carestream, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/20/2014 to US Consignees/customers via Certified Mail on 11/25/2014. Foreign accounts will be notified as soon as possible. The letter described the product, problem and actions to taken. The customers were instructed if they observe a loosened boom to follow the procedure for turning the system off; stop using the device and contact Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the U.S., call your local Service support number. Carestream Health Service representative will contact all customers to schedule a visit to inspect the DRX-Revolution Mobile X-Ray System. If a repair is required it will be completed by a Carestream Field Engineer. If you have any questions, contact the Regulatory Affairs Manager at 585-627-8230 or Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis.

Device

Device Recall Carestream Health DRXRevolution Mobile XRay System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 101 to 764
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, and UNITED KINGDOM.
  • 제품 설명
    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. || The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
  • 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