Class II — Nexstim PLC
| Recalling firm | Nexstim Plc |
|---|---|
| Registered facility | NEXSTIM PLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. |
| 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. |
| Quantity | 11 units. |
| Distribution | Worldwide Distribution - US to GA only, Foreign: Europe |
| Initiated | 2017-03-14 |
| Classified | 2017-06-08 |
| Recall number | Z-2319-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nexstim PLC (Z-2319-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77198/
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