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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Corporate Office

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