Events

Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Toshiba American Medical Systems 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
    62853
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2278-2012
  • 사례 시작날짜
    2008-05-13
  • 사례 출판 날짜
    2012-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111875
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    The status display in the sequence queue window may not change from "current" to "done".
  • 조치
    A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968.

Device

Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504
  • 모델명 / 제조번호(시리얼번호)
    Models MRT-1503 and MRT-1504  " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. || Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • 제조사 주소
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • 제조사 모회사 (2017)
    Canon Inc
  • Source
    USFDA