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.
- Recall Initiated
- March 14, 2017
- Posted
- May 22, 2017
- Recall Number
- Z-2319-2017
- Quantity
- 11 units.
Reason for Recall
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Distribution
Worldwide Distribution - US to GA only, Foreign: Europe
Lot / Code Info
Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.
Root Cause
Use error
Action Taken
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 returned and replaced. Note: If the modified instrument is determined to be part of this recall, please add the instrument to Distributor Card #2. The completed Reconciliation Forms (from medical facilities) should be returned to the US Distributors office DPYUSJointReconFieldActions@its.jnj.com or fax 574-371-4939. Copies of all field action documents should be maintained at the US Distributors office. For questions regarding this recall call 574-371-4917 (M-F; 8 am 5 pm EST) Clinical related questions from surgeons: Direct to the Scientific Information Office at 1-888-554-2482