CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limite
FDA device recall Z-0712-2008 · posted 2008-04-08 · Terminated
Recall details
- Recalling firm
- Neuro-Fitness LLC
- Reason for recall
- No FDA clearance for the .35Hz/.45Hz frequency option on device.
- Action taken
- 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.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- JXK
- Quantity affected
- 3,000 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2007-10-29
- Date posted
- 2008-04-08
- Date terminated
- 2011-09-21
- Location
- Fall City, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CES ULTRA (K062284) | Neuro-Fitness, LLC | 2007-04-05 |