Recall Z-1440-2012 ยท GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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.
| Date | Apr 19, 2012 (initiated Jul 18, 2008) |
| Status | Terminated |
| 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 y |
| Quantity | 59 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and the country UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.