CXR4 Computed Tomography XRay System 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
    52430
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1651-2009
  • 사례 시작날짜
    2009-04-14
  • 사례 출판 날짜
    2009-07-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Incorrect scale on image: a software error can occur if two (2) different field-of-view (fov) settings are registered in a protocol using multi-reconstruction. this could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
  • 조치
    HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.

Device

  • 모델명 / 제조번호(시리얼번호)
    The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution, including Puerto Rico (PR).
  • 제품 설명
    Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
  • Manufacturer

Manufacturer

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