Events

Device Recall NicVue Software version 2.9.2 and 3.0.1. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CareFusion 209 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
    60797
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0737-2012
  • 사례 시작날짜
    2011-12-16
  • 사례 출판 날짜
    2012-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106489
  • 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 device data system - Product Code OUG
  • 원인
    Under certain work flow processes, when selecting a new patient name in nicvue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams.
  • 조치
    The firm, CareFusion, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 16, 2011 to its customers. The letter included a "Description of the issue" and "Actions you must take to correct this issue". The customers were instructed to follow the instructions included with the CD to update all of your NicVue systems; complete and return the SOFTWARE UPDATE VERIFICATION FORM to CareFusion-NeuroCare via fax to: +1 608 829 8517 ; mail to ATTN: Regulatory Affairs, CareFusion-NeuroCare, 1850 Deming Way, Middleton, WI USA 53562 and/or email (PDF) to: Susan.Niesen@CareFusion.com, and if you have transferred any of these products to another location, send those users a copy of this Field Correction notification and notify CareFusion-NeuroCare at +1 800 356 0007 or +1 608 829 8500 ext. 5129, or via email at susan.niesen@carefusion.com of this transfer. If assistance is needed in completing these actions, contact CareFusion NeuroCare Call Center at +1 800 356 0007 or +1 608 829 8500 for further directions; press option 2 for Technical Support.

Device

Device Recall NicVue Software version 2.9.2 and 3.0.1.
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers:   828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA,WV, and WI; and countries of: ARGENTINA, AUSTRALIA, BULGARIA, BANGLADESH, BELGIUM, CHILE COLOMBIA, CYPRUS, CZECH REPUBLIC, CANADA, CHINA, CROATIA, CURACO, DENMARK, DOMINICANA, EGYPT, FRANCE,GERMANY, HUNGARY, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NORWAY, NETHERLANDS, OMAN, PARAGUAY, PERU, POLAND, PORTUGAL, PALESTINIAN, PAKISTAN, PHILIPPINES,QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SERBIA, SLOVENIA, SPAIN, SLOVAKIA, SWITZERLAND, SRI LANKA, RUSSIA, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY, UNITED ARB EMIRATES, and VIET NAM.
  • 제품 설명
    NicVue Software version 2.9.2 and 3.0.1. || Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications, Enter patient information, Import/Export patient information from the Hospital Information System, Move data files, Archive data files on DVD or CDROM.
  • Manufacturer
    CareFusion 209 Inc.

Manufacturer

CareFusion 209 Inc.
  • 제조사 주소
    CareFusion 209 Inc., 1850 Deming Way, Middleton WI 53562-3530
  • Source
    USFDA