The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2320-2017·Announced 2017-06-14

Nexstim Navigated Brain Stimulation System Software Defect Recall

Nexstim PLC is recalling 21 units of the Navigated Brain Stimulation System due to a software defect that may generate duplicate files.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software defect causing duplicate files, which is a low-risk issue without reported injuries or hospitalizations, fitting the Moderate category for minor or low-risk issues.

Plain-English summary

Nexstim PLC is recalling 21 units of the Nexstim Navigated Brain Stimulation System (NBS System) due to a software defect. The affected units include NBS System 4 (software version 4.0 or higher) and NBS System 5 (software version 5.0 or higher). The NBS System is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus and is intended for use by trained clinical professionals for pre-procedural planning.

The recall is being conducted because the NBS software may accidentally generate duplicate copies of one or several files. This defect is a software issue that does not involve a physical malfunction of the hardware or a direct safety hazard to the patient during use.

The affected units were distributed worldwide, specifically to the United States (Georgia) and Europe. Users should contact Nexstim PLC for further instructions regarding the software update to version 4.3.3 for NBS System 4 and version 5.1.1 for NBS System 5.

The recalled product

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…
Manufacturer
Nexstim PLC
Category
Medical Device — Neurological Diagnostic
Hazard
Affected units
21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers: NBS10391245N4
  • NBS11011250N4
  • NBS11071252N4
  • NBS11201252N4
  • NBS11451264N4
  • NBS11491268N4
  • NBS12051269N4
  • NBS12261274N4
  • NBS12341276N4
  • NBS12441278N4
  • NBS13341282N4
  • NBS13431283N4
  • NBS13451284N4
  • NBS13481286N4
  • NBS14011288N4
  • NBS14361295N5
  • NBS14481298N5
  • NBS14491299N5
  • NBS14511301N5
  • NBS15131302N5

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Nexstim PLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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