Events

Device Recall CXR4 Computed Tomography Scanner 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
    50167
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0608-2009
  • 사례 시작날짜
    2008-11-05
  • 사례 출판 날짜
    2009-01-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74889
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • 원인
    Software error: the device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).
  • 조치
    On 11/5/2008 Hitachi Medical Systems sent recall notification letters entitled "URGENT - DEVICE RECALL CORRECTION" to its customers informing them of the problem with the software. They stated that a Hitachi service representative will contact each customer to schedule a software upgrade. For further information, please contact Hitachi Medical Systems America Inc. by telephone at 330-425-1313.

Device

Device Recall CXR4 Computed Tomography Scanner
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: CXR46202 through CXR46248 excluding CXR46207, CXR46208, CXR46215, and CXR46222.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of AZ, CA, DE, FL, ID, IL, IN, KS, KY, LA, MA, MO, NJ, NY, OH, OK, PA, PR, SC, TX, VA, and WI.
  • 제품 설명
    Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
  • 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
  • 제조사 모회사 (2017)
    Hitachi Ltd
  • Source
    USFDA