Cl Il NicoletOne vEEG System

CompanyCarefusion
Date of Enforcement Report 4/28//2010
Class:ll

PRODUCT
NicoletOne vEEG System. Recall # Z-1256-2010

REASON
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..

RECALLING FIRM/MANUFACTURER
CareFusion, Middleton, WI, by letter dated March 3, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2984 US; 3147 OUS

DISTRIBUTION
Nationwide and Internationally

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.