Events

Device Recall Vital Images ViTAL Connect 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vital Images, 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
    45820
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0520-2008
  • 사례 시작날짜
    2007-11-08
  • 사례 출판 날짜
    2008-01-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66214
  • 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
    Picture Archiving and Communications System. - Product Code LLZ
  • 원인
    Standard uptake values (suv) display/update problems; in the way standard uptake values (suv) are displayed in 3d/mpr views. the problem arises when a user draws a selected region of interest in order to calculate the suv statistics of the region. if the user then changes the slice shown by scrolling through additional slices, the original suv measurements will remain on the screen and do not up.
  • 조치
    Customers were notified via telephone (11/7 -11/8/2007) and issued an Urgent Medical Device recall notification letter on 11/8/07. The letter described the problem and product involved. The letter also informed customers they they will provide a free software patch within the next 6-8 weeks.

Device

Device Recall Vital Images ViTAL Connect
  • 모델명 / 제조번호(시리얼번호)
    Versions 4.0 and 4.1 (PET/CT Visualization option in VITALConnent)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide-USA including states of SC, MO, MI, WI, NY, FL, CO, CA, PA, and WA, and countries of England and The Netherlands
  • 제품 설명
    Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)
  • Manufacturer
    Vital Images, Inc.

Manufacturer

Vital Images, Inc.
  • 제조사 주소
    Vital Images, Inc., 3300 Fernbrook Ln N Ste 200, Plymouth MN 55447-5370
  • 제조사 모회사 (2017)
    Canon Inc
  • Source
    USFDA