NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended

FDA device recall Z-0737-2012 · posted 2012-01-13 · Terminated

Recall details

Recalling firm

CareFusion 209 Inc.

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

OUG

Quantity affected

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

Date initiated

2011-12-16

Date posted

2012-01-13

Date terminated

2012-10-11

Location

Middleton, WI