Recall Z-0019-05 ยท JXK Cranial Electrotherapy Stimulator To Treat Depression
Health Directions, Inc
HealthPax (HP-1). Cranial Electrotherapy Stimulator
| Date | Oct 14, 2004 (initiated Apr 8, 2004) |
| Status | Terminated |
| Reason | Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device |
| Root cause | Other |
| Action | The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping. |
| Quantity | 3475 units |
| Distribution | The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.