FDA-Device2016-01-27Class 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 the potential for decreased battery longevity.
Sold states
US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Affected count
29 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-0645-2016Don't want to check this manually?
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