Device 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.
Z-2319-2017
Product summary
- Firm
- Nexstim PLC
- Event
- Event 77198
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units.
- Official record key
device-enforcement:Z-2319-2017
Official wording
Reason: Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Code information: Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.
Distribution pattern: Worldwide Distribution - US to GA only, Foreign: Europe
Derived failure modes
-
Device software or design
Software defect