LivaNova USA Inc recalls VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2

Recall date

January 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2572-2018

FDA classification

Class II

Brand / firm

LivaNova USA Inc

Sold / distributed

Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.

Why it was recalled

Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2