Recall Z-2319-2017 ยท GWF Stimulator, Electrical, Evoked Response
Nexstim PLC
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 su
| Date | May 22, 2017 (initiated Mar 14, 2017) |
| Status | Open, Classified |
| Reason | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. |
| Root cause | Use error |
| Action | DePuy Synthes sent an Urgent Information Recall Notice dated January 6, 2017, to all affected consignee. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately inspect their inventory and return the affected instruments. . If the medical facility is using an instrument that was created or modified by a DePuy Distributor at the request of a surgeon and it is not listed on the Reconciliation Form, please contact the company at 574-371-4917 or 574-371-4756, for evaluation to determine if the instrument should be r |
| Quantity | 11 units. |
| Distribution | Worldwide Distribution - US to GA only, Foreign: Europe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091457 | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM Nexstim OY, Dec 8, 2009 |