HealthPax (HP-1). Cranial Electrotherapy Stimulator
FDA device recall Z-0019-05 · posted 2004-10-14 · Terminated
Recall details
- Recalling firm
- Health Directions, Inc
- Reason for recall
- Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JXK
- Quantity affected
- 3475 units
- Distribution
- The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.
- Date initiated
- 2004-04-08
- Date posted
- 2004-10-14
- Date terminated
- 2004-10-14
- Location
- Morrisville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.