U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Software defect: the nbs software may accidentally generate duplicate copies of one or several files.
조치
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
Worldwide Distribution - US to GA only, Foreign: Europe
제품 설명
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. || 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.