Events

Recall of Device Recall NeuroTherm

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

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
    50136
  • Event Risk Class
    Class 2
  • Event Number
    Z-0838-2009
  • Event Initiated Date
    2008-07-28
  • Event Date Posted
    2009-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74803
  • 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
    Radiofrequency lesion probe - Product Code GXI
  • Reason
    Distal tip may detach from the probe.
  • Action
    NeuroTherrn sales representatives were notified telephonically or through e-mail. End users were notified through visits by NeuroTherm sales representatives on 7/28/08 and 8/15/08. For questions, please contact NeuroTherm, Inc. at 1-978-777-3916.

Device

Device Recall NeuroTherm
  • Model / Serial
    Lot numbers: 080630- 1 B and 080630- 1 C Exp. June 2011
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK,
  • Product Description
    NeuroTherm Simplicity III RF Electrode || Model Number: RFDE-SI || The lesioning of neural tissue.
  • Manufacturer
    Neurotherm, Inc.

Manufacturer

Neurotherm, Inc.
  • Manufacturer Address
    Neurotherm, Inc., 2 De Bush Ave Unit A2, Middleton MA 01949-1679
  • Source
    USFDA