Recall Z-0737-2012 ยท OUG Medical Device Data System
CareFusion 209 Inc.
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 pat
| Date | Jan 13, 2012 (initiated Dec 16, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| Quantity | 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, BANGLADES |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.