Recall – NS Therapy Programming System

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

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

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.