Device Recall SoftWeb Version 4.0.4.10.1 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
    56282
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0099-2011
  • 사례 시작날짜
    2006-06-08
  • 사례 출판 날짜
    2010-10-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-11-03
  • 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
    If a case number is re-used in softweb with softpath, the softpath case is linked to the original mrn in softweb. this causes softpath cases being linked to the wrong patient in softweb. incorrect results on the patient with original mrn and no results on the patient with the second mrn (and the reused case number) are displayed in softweb results query. scc soft computer issued a correction for.
  • 조치
    SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on June 8, 2006. SCC recommended SoftPath/SoftWeb users NOT re-use SoftPath case numbers when cases are cancelled. The generic option setting "Specimen Registration - Standard Settings - Minimum Time to Reactivate Case Number" should be set to "0" so the user is not prompted to reuse the same case number. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    version 4.0.4.10.1.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: 1 hospital in Alaska.
  • 제품 설명
    SoftWeb version 4.0.4.10.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Date: 05/16/2006.
  • Manufacturer

Manufacturer