Exact FDA event identifier

Event 77198

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 14, 2017
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Nexstim PLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Nexstim eXima NBS System Software version 2.2 or higher. 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.

Z-2319-2017

Recall number: Z-2319-2017
Initiated: March 14, 2017
Classification: Class II
Status: Ongoing
Recalling firm: Nexstim PLC
Quantity: 11 units.

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US to GA only, Foreign: Europe

device · product 2 of 2

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.

Z-2320-2017

Recall number: Z-2320-2017
Initiated: March 14, 2017
Classification: Class II
Status: Ongoing
Recalling firm: Nexstim PLC
Quantity: 21

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

Worldwide Distribution - US to GA only, Foreign: Europe