FDAClass IIJune 14, 2017

Nexstim eXima NBS System Software version 2.2 or recall: Software Issue

Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive…

Why was Nexstim eXima NBS System Software version 2.2 or recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.

Product
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive…
Recalling firm
Nexstim PLC
Quantity
11 units.
Distribution
Worldwide Distribution - US to GA only, Foreign: Europe
Recall date
June 14, 2017
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls