Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with 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
    56872
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0362-2011
  • 사례 시작날짜
    2010-06-22
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-09-05
  • 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
    Software, blood bank, stand alone products - Product Code MMH
  • 원인
    Scc soft computer is issuing a correction for softbank ii versions: 23.1.2.X, 23.2.0.X, and 25.0.0.X software applications. functionality issue - for clients generating patient history reports using patient>reports>batch reports>history report option in softbank with softreports activated for patient reports, when the report is generated for more than one patient all of the results for the qualif.
  • 조치
    SCC Soft Computer notified Customers on June 22, 2010, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated June 11, 2010. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; to grant permission to load the required hot fix, and to make the manual correction. For the manual correction to the datapath for patient report layouts, your SoftBank Support Specialist will Coordinate those changes and your validation of affected environments. If you have any questions, contact (727) 789-0100.

Device

  • 모델명 / 제조번호(시리얼번호)
    Versions 23.1.2.x, 23.2.0.x, 25.0.0.x
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: U.S. and country of Canada.
  • 제품 설명
    SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || 23.1:BK040048 || 23.2:BK080020 || 25.0:BK090017 || The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.
  • Manufacturer

Manufacturer