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
- Recall Number
- Z-1440-2012
- Event Number
- 49410
- Firm
- Synaptic Corp
- FEI Number
- 1000117338
- Product Code
- GZJ
- Status
- Terminated
- Root Cause
- PMA
- Initiated
- July 18, 2008
- Posted
- April 19, 2012
- Terminated
- April 19, 2012
- Address
- 3176 S Peoria Ct, Ste 110, Aurora, CO, 80014-3127
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.
Device was distributed without marketing approval.
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.
Worldwide Distribution -- USA (nationwide) and the country UK.
59 units