Z-0737-2012

NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS)

Name: Z-0737-2012 NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS)
Creator: CareFusion 209 Inc.
Published: 2011-12-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-12-16 / Terminated / root cause: software

FDA source

CareFusion 209 Inc. began a recall of 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... on 2011-12-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0737-2012
Status: Terminated
Initiated: 2011-12-16
Posted: 2012-01-13
Terminated: 2012-10-11
Recalling firm: Medtronic, Inc.
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.
Product code: OUG Medical Device Data System
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.
Root cause tag: software
FDA 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: [email protected], 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 [email protected] 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.
Product codes and lots: Part Numbers: 828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)