FDA-Device2014-12-31Class II
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Cyberonics, Inc
Hazard
The recalled product was distributed with an incorrect serial number printed on the device's label.
Sold states
Distributed to PA.
Affected count
1 unit
Manufactured in
100 Cyberonics Blvd, Houston, TX, United States
Products
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0858-2015Don't want to check this manually?
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