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

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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