Events

MRI systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hitachi Medical Systems America 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
    36224
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0029-2007
  • 사례 시작날짜
    2006-08-16
  • 사례 출판 날짜
    2006-10-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48211
  • 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
    Magnetic Resonance Imaging Systems - Product Code LNH
  • 원인
    Image orientation error. when a 3d maximum intensity projection (mip) image data set is transferred from the mri system to a computer workstation via the dicom protocol, the anatomical markers do not change between the images as they rotate.
  • 조치
    On 8/16/2006, Hitachi issued two (2) Device Correction letters. The first letter was addressed to the five (5) customers whose system units are currently ''de-installed''. This letter informs the customers of the problem and asks that the customer(s) please contact the firm''s Customer Service Center on their toll-free tel. # 1-800-800-4925, in order to schedule a device correction should the customer ever re-activate/install their system(s). The second letter, issued to the customers with activated MRP-7000 and/or AIRIS MRI systems, informs the customers of the problem, and states that a HMSA Service (person) will be contacting the customer in order to schedule a device correction which should address the problem.

Device

MRI systems
  • 모델명 / 제조번호(시리얼번호)
    AIRIS - Serial Number Range: A001, AG001-AG039, A901; MRP-7000 - Serial Number Range: 7001- 7154.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Puerto Rico.
  • 제품 설명
    MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • 제조사 주소
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • 제조사 모회사 (2017)
    Hitachi Ltd
  • Source
    USFDA