Recall Z-2319-2017— Nexstim PLC
Class II · Ongoing
Class II FDA medical device recall by Nexstim PLC, initiated 2017-03-14. It names one FDA 510(k) clearance: K091457. 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..
- Recalling firm
- Nexstim PLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-03-14
- Firm location
- Helsinki, N/A, Finland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.