Recall record at a glance
| Official record | Z-2320-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Nexstim PLC |
| Report date | Jun 14, 2017 |
| Recall initiation date | Mar 14, 2017 |
| Quantity | 21 |
| Location | Helsinki, N/A, Finland |
Official product description
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. 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.
Why the product was recalled
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Distribution information
Worldwide Distribution - US to GA only, Foreign: Europe
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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