Nexstim PLC recalls 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…

Recall date

March 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2320-2017

FDA classification

Class II

Brand / firm

Nexstim PLC

Sold / distributed

Worldwide Distribution - US to GA only, Foreign: Europe

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.