Recall Z-1256-2010 ยท GWQ Full-Montage Standard Electroencephalograph
CareFusion
NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.
| Date | Apr 7, 2010 (initiated Mar 8, 2010) |
| Status | Terminated |
| Reason | CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. This may result in the misinterpretation of the left versus right side of the brain. Users are being provided with instructions for removing these protocols and verifying that the deletion has been prop |
| Root cause | Software design |
| Action | Consignees were sent a CareFusion "Urgent Medical Device Correction" letter dated March 3, 2010. The letter described the problem and product involved. The letter included "Action to be taken by Users," "Instructions for deleting protocols," and "Photos-Amplifier label and Headbox insert to be discarded". It also included a "Verification Form" to be completed by recipient. For questions, notify CareFusion-NeuroCare, Attention: Sue Niesen, at (800) 356-0007 ext. 5129, or via email at susan.niesen@carefusion.com |
| Quantity | 2,984 US; 3,147 OUS |
| Distribution | All States in the United States including DC. UNITED ARAB EMIRATES, ALBANIA, ARGENTINA, AUSTRIA, AUSTRALIA, AZERBAIJAN, BANGLADESH, BELGIUM, BULGARIA, BAHRAIN, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECHOSLOVAKIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991054 | BRAVO MULTI-MODALITY SYSTEM Nicolet Biomedical, Inc., Nov 3, 1999 |