FDA Medical Device Recalls (openFDA)
Synaptic Corp: 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.
- Recall number
- Z-1440-2012
- Recalling firm
- 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.
- Status
- Terminated
- Initiated
- 2008-07-18
- Posted
- 2012-04-19
- Terminated
- 2012-04-19
- Reason
- Device was distributed without marketing approval.
- 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
- 59 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and the country UK.
- Lot, serial or model codes
- Synaptic 3600 and 3800 with cranial electrical stimulation, all codes and lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GZJ
- Firm FEI
- 1000117338
- Firm city
- Aurora
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28