Z-2320-2017Class II

NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or...

Name: 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...
Creator: Nexstim PLC
Published: 2017-03-14
License: https://open.fda.gov/license/

Nexstim Inc. / initiated 2017-03-14 / Open, Classified / root cause: software

FDA source

Nexstim PLC began a recall of 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... on 2017-03-14. FDA classified it as Class II and gives the reason as "Software defect: the NBS software may accidentally generate duplicate copies of one or several files". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2320-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-03-14
Posted: 2017-05-22
Recalling firm: Nexstim Inc.
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.
Product code: GWF Stimulator, Electrical, Evoked Response
Reason for recall: Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Root cause tag: software
FDA root cause: Use error
Action: DePuy Synthes sent an Urgent Information Recall Notice dated January 6, 2017, to all affected consignee. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately inspect their inventory and return the affected instruments. . If the medical facility is using an instrument that was created or modified by a DePuy Distributor at the request of a surgeon and it is not listed on the Reconciliation Form, please contact the company at 574-371-4917 or 574-371-4756, for evaluation to determine if the instrument should be returned and replaced. Note: If the modified instrument is determined to be part of this recall, please add the instrument to Distributor Card #2. The completed Reconciliation Forms (from medical facilities) should be returned to the US Distributors office [email protected] or fax 574-371-4939. Copies of all field action documents should be maintained at the US Distributors office. For questions regarding this recall call 574-371-4917 (M-F; 8 am 5 pm EST) Clinical related questions from surgeons: Direct to the Scientific Information Office at 1-888-554-2482
Quantity in commerce: 21
Distribution: Worldwide Distribution - US to GA only, Foreign: Europe
Product codes and lots: Serial numbers: NBS10391245N4, NBS11011250N4, NBS11071252N4, NBS11201252N4, NBS11451264N4, NBS11491268N4, NBS12051269N4, NBS12261274N4, NBS12341276N4, NBS12441278N4, NBS13341282N4, NBS13431283N4, NBS13451284N4, NBS13481286N4, NBS14011288N4, NBS14361295N5, NBS14481298N5, NBS14491299N5, NBS14511301N5, NBS15131302N5, Serial numbers: NBS10391245N4, NBS11011250N4, NBS11071252N4, NBS11451264N4, NBS11491268N4, NBS12051269N4, NBS12261274N4, NBS12341276N4, NBS12441278N4, NBS13341282N4, NBS13431283N4, NBS13451284N4, NBS14011288N4, NBS14481298N5, NBS14491299N5, NBS14511301N5, NBS15131302N5, NBS15271305N5, NBS15371307N5, NBS16031313N5 and NBS16221316N5. Additionally in Nexstim's warehouse (i.e. not distributed NBS 11201256N4, NBS 13481286N4, NBS 14361295N5 and NBS 16371318N5)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2320-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2319-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-06-14	2017-06-08
Z-2320-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-06-14	2017-06-08

Product code GWF

K112881Class IINexstim Navigated Brain Stimulation (Nbs) System 4, Nexstim Nbs System 4 with Nexspeech(tm)Nexstim OY / cleared 2012-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)