FDAFDA · Food and drugs·Recall number Z-2319-2017
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.
Published June 14, 2017 · Recall initiated: March 14, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nexstim PLC
- Distributor
- Worldwide Distribution - US to GA only, Foreign: Europe
- Lot
- Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Finland
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