HealthPax Cranial Electrotherapy Stimulator
FDA device recall Z-1242-2007 · posted 2007-09-26 · Terminated
Recall details
- Recalling firm
- Health Directions, Inc
- Reason for recall
- Peak voltage test result not in acceptable limits.
- Action taken
- 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
- Status
- Terminated
- Product code
- JXK
- Quantity affected
- 212 units
- Distribution
- Worldwide, including USA, Canada, Ireland, and India.
- Date initiated
- 2007-07-19
- Date posted
- 2007-09-26
- Date terminated
- 2008-06-03
- Location
- Levittown, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HP-1 (HEALTHPAX) (K883812) | Healthdirections, Inc. | 1988-11-28 |