FDA-Device2015-05-06Class II
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Cyberonics, Inc
Hazard
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
Sold states
AR, TX, GA, CA, MI, IN, FL, AZ, NV
Affected count
13 units
Manufactured in
100 Cyberonics Blvd, Houston, TX, United States
Products
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1526-2015Don't want to check this manually?
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