FDA-Device2018-08-08Class II
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
LivaNova USA Inc
Hazard
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Sold states
Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.
Affected count
243 devices total
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
Products
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2572-2018Don't want to check this manually?
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