Events

Softbank 25.5.2.025.5.3.1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Soft Computer Consultants, Inc. 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
    76046
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1098-2017
  • 사례 시작날짜
    2016-10-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152049
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • 원인
    Software error. potential for incorrect results.
  • 조치
    Consignees were sent a recall notification, dated 10/06/2016, providing instructions for software correction. The firm indicates that the issue will be resolved with a mandatory hot fix. Hot fix will be released when its effectiveness is confirmed. Consignees are instructed to acknowledge receipt of the recall notification and grant permission for the recalling firm to load the hot fix when available. The firm can be contacted by calling Technical Support at 1-800-763-8522. Until the hot fix is available, consignees can still operate the software by exiting (Esc-Quit) the Test Verify option after each save changes (F12-Accept).

Device

Softbank 25.5.2.025.5.3.1
  • 모델명 / 제조번호(시리얼번호)
    Version: 35.5.2.0, 25.5.3.0, 25.5.3.1
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
  • 제품 설명
    Softbank software || Product Usage: || Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
  • Manufacturer
    Soft Computer Consultants, Inc.

Manufacturer

Soft Computer Consultants, Inc.
  • 제조사 주소
    Soft Computer Consultants, Inc., 5400 Tech Data Dr, Clearwater FL 33760-3116
  • 제조사 모회사 (2017)
    Soft Computer Consultants Inc.
  • Source
    USFDA