Company: Cyberonics, Inc., ,
Date of Enforcement Report 2/6/2008
Class:lll
PRODUCT
Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher, Recall # 0568-2008
REASON
Screen Freezes– The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input.
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by letter on October 1, 2007 and November 15, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6642 units
DISTRIBUTION
Nationwide and Internationally
