Device Recall SoftPath GUI Versions 3.17 and 4.1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 SCC Soft Computer 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
    56277
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0089-2011
  • 사례 시작날짜
    2003-12-30
  • 사례 출판 날짜
    2010-10-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-11-03
  • 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
    Medical computers and software - Product Code LNX
  • 원인
    Softpath cases with word perfect documents that were not signed out in ascii are printing in gui as a converted document from word perfect to pdf document instead of the current ms word document. this affects clients upgrading from ascii to softpath gui 3.17.7.6 version. all affected clients have been notified and corrections have been made.
  • 조치
    SCC Soft Computer issued Risk-to-Health notifications with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System. beginning on December 30, 2003. Clients were instructed to sign out all Word Perfect documents before upgrading to GUI. The correction for this anomaly is to upgrade to the latest release of version 3.17.7 or 3.17.8. Clients were asked to acknowledge receipt of this Task and indicate whether they would like to take the correction at this time. When the client decides to accept the correction a new task will be created to initiate the patch using the Task Management System.

Device

  • 모델명 / 제조번호(시리얼번호)
    Version 3.17.7.6
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to the states of IN, NC, NH, and NJ.
  • 제품 설명
    SoftPath GUI Versions 3.17 and 4.1. || SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. || Manufactured: Version 3.17.7.6 10/23/2003
  • Manufacturer

Manufacturer