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Terminated

CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024

FDA Recall Z-0712-2008 · Posted 2008-04-08

Recalling FirmNeuro-Fitness LLC
Recall StatusTerminated
Product CodeJXK
Date Initiated2007-10-29
Date Terminated2011-09-21
Product Quantity3,000 units

Reason for Recall

No FDA clearance for the .35Hz/.45Hz frequency option on device.

Firm 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.

Root Cause

Finished device change control

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062284CES ULTRANeuro-Fitness, LLC · 2007-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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