The Recall Desk
ModerateFDA (Devices)·Z-2319-2017·Announced 2017-06-14

Nexstim eXima NBS System Software Recalled for File Duplication Defect

Nexstim PLC is recalling 11 units of the eXima NBS System due to a software defect that may generate duplicate files.

What this means for you

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. The hazard is a software defect causing file duplication, which is a functional error rather than a direct physical injury risk, fitting the criteria for a moderate severity recall without reported injuries.

Plain-English summary

Nexstim PLC is recalling 11 units of the Nexstim eXima NBS System Software version 2.2 or higher. The recall is due to a software defect that may accidentally generate duplicate copies of one or several files.

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. It provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The system is not intended to be used during a surgical procedure and is intended to be used by trained clinical professionals.

The affected units were distributed in the United States (Georgia only) and Europe. The specific serial numbers for the recalled units are NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, and NBS166. Unit NBS158 has been scrapped.

The recalled product

Product
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 a
Manufacturer
Nexstim PLC
Category
Medical Device — Neurological Diagnostic
Hazard
Affected units
11

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 (11)

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

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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