Company:CareFusion 209 Inc
Date of Enforcement Report 1/25/12
Class ll:
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. Part Numbers: 828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500. Recall # Z-0737-2012
REASON
CareFusion recently discovered that NicVue versions 2.9.2 and 3.0.1 contains a software issue that may affect some workflows. To prevent this possibility, your NicVue version 2.9.2 must be updated to 2.9.3 and 3.0.1 must be updated to NicVue version 3.0.2. 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. When the exam record is opened in the device application software, the correct patient name associated with that record is displayed at the top of the screen, but it may not be the intended patient’s record.
RECALLING FIRM/MANUFACTURER
Recalling Firm: CareFusion 209 Inc., Middleton, WI, by letter dated December 16, 2011.
Manufacturers: CareFusion 209 Inc., Middleton, WI;
VIASYS Healthcare-Intermed Precision Subsidiary, Galway, Ireland. Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
11676 (614 Nationwide; 1062 Internationally)
DISTRIBUTION
Nationwide and Internationally
