Recall – NS Therapy Programming System

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

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

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Need info?  Email us at training@softwarecpr.com

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