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U.S. Department of Health and Human Services

Class 2 Device Recall NicVue Software version 2.9.2 and 3.0.1.

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 Class 2 Recall
NicVue Software version 2.9.2 and 3.0.1.
see related information
Date Posted January 13, 2012
Recall Status1 Terminated on October 11, 2012
Recall Number Z-0737-2012
Recall Event ID 60797
Product Classification Medical Device Data System - Product Code OUG
Product 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.
Code Information Part Numbers: 828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500
Recalling Firm/
Manufacturer
CareFusion 209 Inc.
1850 Deming Way
Middleton, Wisconsin 53562-3530
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 1,676 ( 1062 OUS, 614 US)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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