Nexstim eXima NBS System Software version 2 — Class II medical device recall Z-2319-2017
Ongoing recall by Nexstim PLC, reported 2017-06-14. Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
| Recall number | Z-2319-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nexstim PLC, Helsinki, N/A, Finland |
| Recall initiated | 2017-03-14 |
| Classified | 2017-06-08 |
| Reported by FDA | 2017-06-14 |
| Quantity | 11 units |
| Reason classes | software |
| Serial numbers | NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS158, NBS159, NBS163, NBS164, NBS166 |
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 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.
Reason for recall
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2319-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.