FDA-Device2015-11-25Class II
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Cyberonics, Inc
Hazard
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
Sold states
US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.
Affected count
27 units
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
Products
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0280-2016Don't want to check this manually?
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