Recall Z-0712-2008 ยท JXK Cranial Electrotherapy Stimulator To Treat Depression
Neuro-Fitness LLC
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
| Date | Apr 8, 2008 (initiated Oct 29, 2007) |
| Status | Terminated |
| Reason | No FDA clearance for the .35Hz/.45Hz frequency option on device. |
| Root cause | Finished device change control |
| Action | Consignees were notified of this recall by an Urgent Device Recall Letter sent via U.S. First Class mail on 10/29/07. The letter instructs users to contact the recalling firm to make arrangements to return the device. The letter also instructs users to return an enclosed response card. Consignees who do not respond will receive a follow-up telephone call two weeks after initial mailing of recall notice. For more information, contact firm at 1-866-937-4237. |
| Quantity | 3,000 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062284 | CES ULTRA Neuro-Fitness, LLC, Apr 5, 2007 |