Jun

2017

Nexstim NBS System 4 and 5 Cl II

Company: Nexstim PLC
Date of Enforcement Report 6/14/2017
Class lI:

PRODUCT

NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus.
Recall Number Z-2320-2017

REASON
Software defect: the NBS software may accidentally generate duplicate copies of one or several files..

RECALLING FIRM/MANUFACTURER
Nexstim PLC, Helsinki, Finland on 3/14/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
21

DISTRIBUTION
Worldwide Distribution – US to GA only, Foreign: Europe.

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About the author

Amy Sellers

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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Nexstim NBS System 4 and 5 Cl II

Amy Sellers

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