Date of Enforcement Report 4/28//2010
NicoletOne vEEG System. Recall # Z-1256-2010
CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. The field correction involves providing users with instructions for removing the subject protocols and verifying the deletion has been properly conducted. CareFusion NeuroCare believes that the products in the field with the original configuration are not likely to cause any adverse events for patients..
CareFusion, Middleton, WI, by letter dated March 3, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2984 US; 3147 OUS
Nationwide and Internationally