Nexstim PLC: Medical Device Recall in 2017 - (Recall #: Z-2320-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 14, 2017

Date Posted: June 14, 2017

Recall Number: Z-2320-2017

Event ID: 77198

Reason for Recall:

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

Status: Ongoing

Product Quantity: 21

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

Voluntary or Mandated:

Voluntary: Firm initiated