Device Recall NicVue Software version 2.9.2 and 3.0.1.

  • Modelo / Serial
    Part Numbers:   828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    CareFusion 209 Inc., 1850 Deming Way, Middleton WI 53562-3530
  • Source
    USFDA