Events

Device Recall FUJIFILM FDR Visionary Suite with CH200 stationary xray system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fujifilm Medical Systems U.S.A., 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
    78644
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0232-2018
  • 사례 시작날짜
    2017-06-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160059
  • 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
    A potential issue in the x-ray tube ceiling unit ch-200 which constitutes the digital radiography system fdr visionary suite. the x-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
  • 조치
    FUJIFILM Medical Systems U.S. A. Inc. (FMSU) sent "Urgent: Medial Device Correction" recall notification letter dated June 21, 2017 to all Customers. Customers were notified of the recall, potential issue, potential hazard, description of the issue, the actions planned to correct the issue, the actions to be taken by the customer and contact information. A Customer Feedback Form was provided accompanying the letter. FMSU service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. As FMSUs planned field correction at the affected sites, FMSU will install the additional protective parts preventing the X-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. For further questions, please call (203) 324-2000.

Device

Device Recall FUJIFILM FDR Visionary Suite with CH200 stationary xray system
  • 모델명 / 제조번호(시리얼번호)
    UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001.  Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution.
  • 제품 설명
    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) || The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • 제조사 주소
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • 제조사 모회사 (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA