Z-1440-2012

Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO...

Name: Z-1440-2012 Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO...
Creator: Synaptic Corp
Published: 2008-07-18
License: https://open.fda.gov/license/

The Synaptic Corp. / initiated 2008-07-18 / Terminated

FDA source

Synaptic Corp began a recall of Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. Transcutaneous nerve stimulation for pain relief and other... on 2008-07-18. The reason FDA records is "Device was distributed without marketing approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1440-2012
Status: Terminated
Initiated: 2008-07-18
Posted: 2012-04-19
Terminated: 2012-04-19
Recalling firm: The Synaptic Corp.
Product: 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.
Product code: GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Reason for recall: Device was distributed without marketing approval.
FDA root cause: PMA
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.
Quantity in commerce: 59 units
Distribution: Worldwide Distribution -- USA (nationwide) and the country UK.
Product codes and lots: Synaptic 3600 and 3800 with cranial electrical stimulation, all codes and lots.

Product code GZJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)