Recall Z-1242-2007 ยท JXK Cranial Electrotherapy Stimulator To Treat Depression
Health Directions, Inc
HealthPax Cranial Electrotherapy Stimulator
| Date | Sep 26, 2007 (initiated Jul 19, 2007) |
| Status | Terminated |
| Reason | Peak voltage test result not in acceptable limits. |
| Root cause | Other |
| 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. |
| Quantity | 212 units |
| Distribution | Worldwide, including USA, Canada, Ireland, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883812 | HP-1 (HEALTHPAX) Healthdirections, Inc., Nov 28, 1988 |