Events

Device Recall Shimadzu FDR Visionary Suite 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Shimadzu Medical Systems Usa Com 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
    77351
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2655-2017
  • 사례 시작날짜
    2017-05-23
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155811
  • 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
    Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
  • 조치
    Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers. The firm will implement a voluntary recall/field corrective action to add 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. Customers with questions were instructed to call 800-228-1429.

Device

Device Recall Shimadzu FDR Visionary Suite
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan
  • 제품 설명
    SHIMADZU FDR Visionary || Catalog Number: FDR Visionary Suite || Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
  • Manufacturer
    Shimadzu Medical Systems Usa Com

Manufacturer

Shimadzu Medical Systems Usa Com
  • 제조사 주소
    Shimadzu Medical Systems Usa Com, 20101 S Vermont Ave, Torrance CA 90502-1328
  • 제조사 모회사 (2017)
    Shimadzu Corp.
  • Source
    USFDA