Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2320-2017 — 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. T

U.S. FDA — Device Enforcement · Finland · 2017-03-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2320-2017
Date of alert: 2017-03-14
Country / jurisdiction: Finland
Risk level: Class II
Risk type: recall
Brand: Nexstim PLC
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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