Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NBS System 4 (sw version 4.0 or higher) Recalled by Nexstim PLC Due to Software defect: the NBS software may accidentally generate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nexstim PLC directly.
Affected Products
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.
Quantity: 21
Why Was This Recalled?
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Where Was This Sold?
This product was distributed to 1 state: GA
About Nexstim PLC
Nexstim PLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report