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U.S. Department of Health and Human Services

Class 2 Device Recall Nexstim

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  Class 2 Device Recall Nexstim see related information
Date Initiated by Firm March 14, 2017
Date Posted May 22, 2017
Recall Status1 Open3, Classified
Recall Number Z-2319-2017
Recall Event ID 77198
510(K)Number K091457  
Product Classification Stimulator, electrical, evoked response - Product Code GWF
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.
Code Information Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.
Recalling Firm/
Manufacturer		 Nexstim PLC
Elimaenkatu 9B
Helsinki Finland
For Additional Information Contact
312-373-3704
Manufacturer Reason
for Recall		 Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
FDA Determined
Cause 2		 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 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
Quantity in Commerce 11 units.
Distribution Worldwide Distribution - US to GA only, Foreign: Europe
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GWF and Original Applicant = NEXSTIM OY
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