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Terminated

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.

FDA Recall Z-1440-2012 · Posted 2012-04-19

Recalling FirmSynaptic Corp
Recall StatusTerminated
Product CodeGZJ
Date Initiated2008-07-18
Date Terminated2012-04-19
Product Quantity59 units

Reason for Recall

Device was distributed without marketing approval.

Firm 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.

Root Cause

PMA

Distribution Pattern

Worldwide Distribution -- USA (nationwide) and the country UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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