Events

Recall of Device Recall Synaptic

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

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
    49410
  • Event Risk Class
    Class 2
  • Event Number
    Z-1440-2012
  • Event Initiated Date
    2008-07-18
  • Event Date Posted
    2012-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108523
  • 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, nerve, transcutaneous, for pain relief - Product Code GZJ
  • Reason
    Device was distributed without marketing approval.
  • Action
    Synaptic Corp, sent a Urgent Medical Device Recall letter dated July 14th, 2008, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. The customer was instructed to return your 3600 and or 3800 devices so that the cranial stimulator can be removed and destroyed. Please call 1-800-685-7246 to schedule pick up of your device.. Complete the enclosed Confirmation Form and return it ( postage paid) to Synaptic Corp. It is important that you return the attached response confirmation form even if you do not have the (CES) module in your model. Should you have any questions about this recall please call 1-800-685-7246 ext. 101.

Device

Device Recall Synaptic
  • Model / Serial
    Synaptic 3600 and 3800 with cranial electrical stimulation, all codes and lots.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the country UK.
  • Product Description
    Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. || Transcutaneous nerve stimulation for pain relief and other medical treatment uses.
  • Manufacturer
    Synaptic Corp

Manufacturer

Synaptic Corp
  • Manufacturer Address
    Synaptic Corp, 3176 S Peoria Ct Ste 110, Aurora CO 80014-3127
  • Source
    USFDA