Class 2 Device Recall NicVue Software version 2.9.2 and 3.0.1.

• Date Initiated by Firm: December 16, 2011
• Date Posted: January 13, 2012
• Recall Status: 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 WI 53562-3530
• For Additional Information Contact: 608-829-8500
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.