Events

IMPAX Cardiovascular IMPAX CV12 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGFA Healthcare Corp. 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
    72411
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0283-2016
  • 사례 시작날짜
    2015-09-01
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140966
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    Customers have experienced impax cv software, specifically, demographics manager (dm), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
  • 조치
    An Urgent Field Safety Notice was sent to accounts via email on 9/1/2015. The letter described the safety alert. Customers were informed of the problem and that Service would be contacting them to arrange a date to deploy the corrective action and install the Service Update at their facility. An acknowledgement was included which was to be faxed back or emailed back to Agfa.

Device

IMPAX Cardiovascular IMPAX CV12
  • 모델명 / 제조번호(시리얼번호)
    Model # L9M2100
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.
  • 제품 설명
    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • 제조사 주소
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • 제조사 모회사 (2017)
    Agfa-Gevaert NV
  • Source
    USFDA