Z-2319-2017 Class II Ongoing
FDA device recall Z-2319-2017 was initiated by Nexstim PLC on March 14, 2017 and is designated Class II. Reason for recall: Software defect: the NBS software may accidentally generate duplicate copies of one or several files. The recall status is ongoing. Affected quantity: 11 units..
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- March 14, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units.
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.
Distribution Pattern
Worldwide Distribution - US to GA only, Foreign: Europe
Code Information
Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.