Device Recall SoftPath GUI Releases 3.17 through 4.1.0. 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
    56275
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0067-2011
  • 사례 시작날짜
    2007-03-28
  • 사례 출판 날짜
    2010-10-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-10-19
  • 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
    Scc soft computer, clearwater, fl issued a correction for softpath gui releases 3.17 and 4.1 in march 2007 for clients with high volume output of final reports who use the batch print for final reports in the scheduler, there is a potential for some reports not printing. this issue was corrected for the one affected user in october 2003.
  • 조치
    SCC Soft Computer sent a SAFETY NOTIFICATION TASK VERBIAGE dated January 5, 2004, to one client. The Notice identified the product, the problem, and the action to be taken by the client. SCC recommended the client set the Search Date Range to a small enough range to assure that the number of cases scanned during the job would be less than 10,000. The client was asked to acknowledge receipt of the task and to indicate if the Workflow or functionality was used/not used and Agree to use the alternative working solution. For any questions regarding this recall call (727) 780-0100, ext. 4235.

Device

  • 모델명 / 제조번호(시리얼번호)
    Versions 3.17.5, 3.17.6, 3.17.7, 3.17.8, 4.1.0, and 4.1.1.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide - USA, including the states of CA, CO, CT, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, SD, TX, WI, and WV
  • 제품 설명
    SoftPath GUI Releases 3.17 through 4.1.0. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || Version 3.17.5 10/14/2003. || Version 3.17.6 03/28/2003. || Version 3.17.7 07/02/2003. || Version 3.17.8 03/03/2004. || Version 4.1.0 07/03/2003. || Version 4.1.1 10/03/2003. || Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.
  • Manufacturer

Manufacturer