Device Recall SoftPath GUI 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
    60420
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0209-2012
  • 사례 시작날짜
    2011-07-13
  • 사례 출판 날짜
    2011-11-17
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-17
  • 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
    Soft computer, clearwater, fl, initiated a correction on the following softpath gui versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. softpath architecture does not correctly handle ap macros and data fields inside report sections that are stored in the database. improper information can be displayed in all places where the diagnosis from the database is read and displayed.
  • 조치
    The firm, SCC Soft Computer, sent a "CORRECTION COMMUNICATION" notice on July 13, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to restrict security access to the template set-up files and to acknowledge receipt of the notice; grant SCC personnel permission to check their report templates and correct any that are affected; indicate if they wish to schedule the utility to be run and if they would like to have the SoftWeb parameter PathPDFLinkOnly set to "Y". SCC will review the templates on the customers systems; discuss any irregularities requiring change and move or remove AP macros and data elements as needed. If you have any questions, contact the Director of Quality Management at (727)789-0100.

Device

  • 모델명 / 제조번호(시리얼번호)
    SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI, WV including Puerto Rico; country of Canada.
  • 제품 설명
    SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
  • Manufacturer

Manufacturer