Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is

FDA device recall Z-2319-2017 · posted 2017-05-22 · Open, Classified

Recall details

Recalling firm

Nexstim PLC

Reason for recall

Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

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

Root cause

Use error

Status

Open, Classified

Product code

GWF

Quantity affected

11 units.

Distribution

Worldwide Distribution - US to GA only, Foreign: Europe

Date initiated

2017-03-14

Date posted

2017-05-22

Location

Helsinki, Finland

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