Company:Cyberonics, Incl
Date of Enforcement Report:1/31/2007
Class:ll
PRODUCT
a) Cyberonics VNS Therapy System, Model 250-‘HAND HELD’
programming software v6.1, v6.1.7, v7.0 and v7.1.3,
Recall # Z-0341-2007;
b) Handhelds-Cyberonics VNS Therapy System, Model 2500-‘Handhelds’
preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3,
Recall # Z-0342-2007
REASON
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
CODE
a) For Software v6.1: 10-005-9400 and 10-006-0900; For Software v6.1.7:
10-0007-2400 and 10-0007-2500; For Software v7.0: 10-0007-4100
and 10-0007-2500; For Software v7.1.3: 10-0007-8400 and 10-0007-8500;
b) For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300;
For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609
and 77-0000-7000; For Handheld v7.0: 10-0007-4300;
For Handheld v7.1.3: 10-0007-8600.
RECALLING FIRM/MANUFACTURER
SCyberonics, Inc., Houston, TX, by safety alert on November 14, 2006. Firm initiated recall is onging.
VOLUME OF PRODUCT IN COMMERCE
3,538 Software; 7,404 Handheld PCs
DISTRIBUTION
Nationwide and Internationally
