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LivaNova USA Inc recalls VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Recalled August 8, 2018 · FDA recall Z-2572-2018 · LivaNova USA
Hazard
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. · FDA Class II
Units
243 devices total
Sold at
Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.
Description
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Product
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Manufacturer(s)
LivaNova USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →