Z-0712-2008

CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco...

Name: Z-0712-2008 CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco...
Creator: Neuro-Fitness LLC
Published: 2007-10-29
License: https://open.fda.gov/license/

Neuro-Fitness LLC / initiated 2007-10-29 / Terminated

FDA source

Neuro-Fitness LLC began a recall of CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC... on 2007-10-29. The reason FDA records is "No FDA clearance for the .35Hz/.45Hz frequency option on device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0712-2008
Status: Terminated
Initiated: 2007-10-29
Posted: 2008-04-08
Terminated: 2011-09-21
Recalling firm: Neuro-Fitness LLC
Product: CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
Product code: JXK Cranial Electrotherapy Stimulator To Treat Depression
Reason for recall: No FDA clearance for the .35Hz/.45Hz frequency option on device.
FDA 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 in commerce: 3,000 units
Distribution: Worldwide Distribution
Product codes and lots: Serial Numbers: 1000 through 3999.

Product code JXK

K062284Class IICes UltraNeuro-Fitness, LLC / cleared 2007-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)