FDA Medical Device Recalls (openFDA)
Health Directions, Inc: HealthPax (HP-1). Cranial Electrotherapy Stimulator
- Recall number
- Z-0019-05
- Recalling firm
- Health Directions, Inc
- Product
- HealthPax (HP-1). Cranial Electrotherapy Stimulator
- Status
- Terminated
- Initiated
- 2004-04-08
- Posted
- 2004-10-14
- Terminated
- 2004-10-14
- 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.
- Lot, serial or model codes
- HealthPax (HP-1)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JXK
- Firm FEI
- 2529026
- Firm city
- Morrisville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28