Company: LivaNova USA Inc
Date of Enforcement Report: 8/8/2018
Class II:

PRODUCT
NS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2

Recall Number: Z-2572-2018

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

RECALLING FIRM/MANUFACTURER
LivaNova USA Inc., Houston, TX on 7/25/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
243 devices total

DISTRIBUTION
Nationwide