Device Recall SoftID.NET versions 2.0.0.6 2.0.0.19. 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
    56873
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0360-2011
  • 사례 시작날짜
    2009-08-28
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-11-16
  • 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
    Calculator/data processing module, for clinical use - Product Code LNX
  • 원인
    Scc soft computer issued a correction for softid.Net versions 2.0.0.6 - 2.0.0.19. when using the cancel functionality, if the collection list refreshes during the transaction and changes the position of the patient on the list, the wrong patient order can be cancelled. all affected clients have been notified.
  • 조치
    SCC Soft Computer notified Customers on August 28, 2009, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated August 17, 2009. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; document a request to load the software, if they wish to receive the correction; document that the Alternative Working Solution will be used by the customers facility until the correction has been taken live. If you have any questions, contact (727) 789-0100.

Device

  • 모델명 / 제조번호(시리얼번호)
    Versions: SoftID.NET 2.0.0.6 - 4/3/2007,  SoftID.NET 2.0.0.7 - 6/21/2007,  SoftID.NET 2.0.0.8 - 8/29/2007,  SoftID.NET 2.0.0.9 - 10/01/2007,  SoftID.NET 2.0.0.10 - 10/25/2007,  SoftID.NET 2.0.0.11 - 11/07/2007,  SoftID.NET 2.0.0.12 - 2/08/2008,  SoftID.NET 2.0.0.13 - 5/13/2008,  SoftID.NET 2.0.0.14 - 6/12/2008,  SoftID.NET 2.0.0.15 - 8/15/2008,  SoftID.NET 2.0.0.16 - 10/15/2008,  SoftID.NET 2.0.0.17 - 12/15/2008,  SoftID.NET 2.0.0.18 - 2/02/2009,  SoftID.NET 2.0.0.19 - 5/18/2009.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.
  • 제품 설명
    SoftID.NET versions 2.0.0.6 - 2.0.0.19. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).
  • Manufacturer

Manufacturer