SoftReports 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
    60416
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0362-2012
  • 사례 시작날짜
    2011-10-25
  • 사례 출판 날짜
    2011-12-02
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-16
  • 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
    On 10/25/2011 scc soft computer, clearwater, fl initiated a correction on the softreports version 1.1.8.2.4 with hot fixes 1.7199.7 or 1.7200.7. when softreports designer opened a layout, the system did not load the layout with the previously saved value in the newpage property. this caused multiple patient records to be printed on the same page. all affected clients were notified on the issue on.
  • 조치
    SCC Soft Computer sent a "Correction Notification" letter dated October 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The hot fixes that were previously loaded which introduced this issue were corrected and delivered to all affected customers as a mandatory correction in hot fixes 1.7199.8 and 1.7200.8 and higher.

Device

  • 모델명 / 제조번호(시리얼번호)
    SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. || SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.
  • Manufacturer

Manufacturer