Z-0019-05

HealthPax (HP-1). Cranial Electrotherapy Stimulator

Name: Z-0019-05 HealthPax (HP-1). Cranial Electrotherapy Stimulator
Creator: Health Directions, Inc
Published: 2004-04-08
License: https://open.fda.gov/license/

Health Directions, Inc / initiated 2004-04-08 / Terminated

FDA source

Health Directions, Inc began a recall of HealthPax (HP-1). Cranial Electrotherapy Stimulator on 2004-04-08. The reason FDA records is "Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0019-05
Status: Terminated
Initiated: 2004-04-08
Posted: 2004-10-14
Terminated: 2004-10-14
Recalling firm: Health Directions, Inc
Product: HealthPax (HP-1). Cranial Electrotherapy Stimulator
Product code: JXK Cranial Electrotherapy Stimulator To Treat Depression
Reason for recall: Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
FDA 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 in commerce: 3475 units
Distribution: The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.
Product codes and lots: HealthPax (HP-1)

Product code JXK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)