HealthPax Cranial Electrotherapy Stimulator
FDA Recall Z-1242-2007 · Posted 2007-09-26
Recalling FirmHealth Directions, Inc
Recall StatusTerminated
Product CodeJXK
Date Initiated2007-07-19
Date Terminated2008-06-03
Product Quantity212 units
Reason for Recall
Peak voltage test result not in acceptable limits.
Firm Action
The recalling firm sent a recall letter 07/30/2007 to all their customers. The letter indicated that it is necessary to return the product for testing and the device will either be returned or if necessary replaced. Each unit will be tested with an oscilloscope device to determine whether it meets or fails design specifications. The recalling firm will reimburse shipping costs.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Canada, Ireland, and India.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.