Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. 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
    60451
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0355-2012
  • 사례 시작날짜
    2011-06-13
  • 사례 출판 날짜
    2011-12-02
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-05-31
  • 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
    On 06/13/2011, scc soft computer initiated a correction on the following softpath gui versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. a client reported when they verified the contents of the fax reports, they found one of the specimen diagnoses to be missing. parts a through d were present as well as part f, however, part e diagnosis was missing for one of the patient reports. all affected clients wer.
  • 조치
    SCC Soft Computer initiated a Field Correction on June 13, 2011. All customers with affected software have been notified of this issue. SCC recommends until the corrected patch is loaded to temporarily use one of the following alternative working solutions: 1. Use MS Word Editor functionality within SoftPath application for creating patient reports. In order to ensure Text Control editor is not inadvertently activated, the templates for Text Control editor will be deleted and reinstalled at the clients request by their SCC representative after receipt of the correction. 2. In Report Template set-up, the bottom margin should be made slightly larger than the size of the footer plus its distance from the bottom page border. For further explanation, please consult your SCC representative for further details, or call (727) 789-0100.

Device

  • 모델명 / 제조번호(시리얼번호)
    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.
  • 제품 설명
    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. || 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