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Terminated

HealthPax (HP-1). Cranial Electrotherapy Stimulator

FDA Recall Z-0019-05 · Posted 2004-10-14

Recalling FirmHealth Directions, Inc
Recall StatusTerminated
Product CodeJXK
Date Initiated2004-04-08
Date Terminated2004-10-14
Product Quantity3475 units

Reason for Recall

Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device

Firm 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.

Root Cause

Other

Distribution Pattern

The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.

Official Source

View FDA Recall →

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

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