SoftLab GUI Version 4.0.1.0 4.0.1.16, 4.0.2.0 4.0.2.10, 4.0.3.0 4.0.3.13, and 4.0.4.0 4.0.4. 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
    56867
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0365-2011
  • 사례 시작날짜
    2009-04-01
  • 사례 출판 날짜
    2010-11-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-08-07
  • 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
    Calculator/Data Processing Module for Clinical Use - Product Code JQP
  • 원인
    Clients using patient maintenance to perform moves of stays may send the wrong billing number during an adt update to softweb, softpath or softmedia. the wrong billing number can come from a different patient in order entry. only moves of stays are affected.
  • 조치
    Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.

Device

  • 모델명 / 제조번호(시리얼번호)
    Versions: 4.0.1.0 - 4.0.1.16; 4.0.2.0 - 4.0.2.10; 4.0.3.0 - 4.0.3.13; and 4.0.4.0 - 4.0.4.5.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || 4.0.1.0 - 08/06/04, || 4.0.1.4 - 10/18/04, || 4.0.1.5 - 01/18/04, || 4.0.1.6 - 12/15/04, || 4.0.1.7 - 01/10/05, || 4.0.1.8 - 03/29/05, || 4.0.1.9 - 05/06/05, || 4.0.1.13 - 01/25/06, || 4.0.1.14 - 03/26/07 || 4.0.1.15 - 05/02/07, || 4.0.1.16 - 08/22/08, || 4.0.2.0 - 04/08/05, || 4.0.2.1 - 08/13/08, || 4.0.2.2 - 06/06/05, || 4.0.2.3 - 09/19/05, || 4.0.2.4 - 09/19/05, || 4.0.2.5 - 09/19/05, || 4.0.2.7 - 02/13/06, || 4.0.2.8 - 12/12/06, || 4.0.2.9 - 02/20/08, || 04.2.10 - 08/13/08, || 4.0.3.2 - 05/17/06, || 4.0.3.3 - 09/18/06, || 4.0.3.4 - 09/27/06, || 4.0.3.5 - 11/29/06, || 4.0.3.6 - 06/22/07, || 4.0.3.7 - 03/28/07, || 4.0.3.8 - 06/22/07, || 4.0.3.9 - 08/03/07, || 4.0.3.10 - 08/24/07, || 4.0.3.11 - 09/24/07, || 4.0.3.12 - 03/07/08, || 4.0.3.13 - 06/13/08, || 4.0.4.2 - 02/22/08, || 4.0.4.3 - 05/22/08, || 4.0.4.4 - 07/28/08, || 4.0.4.5 - 05/04/09. || Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.
  • Manufacturer

Manufacturer