FDA Device recall Z-2319-2017
Nexstim eXima NBS System Software version 2.2 or higher
- FDA Device
- Class II
- ongoing
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of Nexstim eXima NBS System Software version 2.2 or higher by Nexstim, citing software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2319-2017 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-03-14 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nexstim |
| Distribution | GA |
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
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Identifiers
| code_info | Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2319-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.