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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
Recalled June 14, 2017 · FDA recall Z-2320-2017 · Nexstim
Hazard
Software defect: the NBS software may accidentally generate duplicate copies of one or several files. · FDA Class II
Units
21
Sold at
Worldwide Distribution - US to GA only, Foreign: Europe
Description
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
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. 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.
Manufacturer(s)
Nexstim PLC
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →