Events

Recall of Device Recall Nexstim

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nexstim PLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77198
  • Event Risk Class
    Class 2
  • Event Number
    Z-2319-2017
  • Event Initiated Date
    2017-03-14
  • Event Date Posted
    2017-05-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155419
  • Notes / Alerts
    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.
  • Extra notes in the data
    Stimulator, electrical, evoked response - Product Code GWF
  • Reason
    Software defect: the nbs software may accidentally generate duplicate copies of one or several files.
  • 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

Device

Device Recall Nexstim
  • Model / Serial
    Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to GA only, Foreign: Europe
  • Product Description
    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.
  • Manufacturer
    Nexstim PLC

Manufacturer

Nexstim PLC
  • Manufacturer Address
    Nexstim PLC, Elimaenkatu 9B, Helsinki Finland
  • Manufacturer Parent Company (2017)
    Nordea Bank Ab
  • Source
    USFDA