Date Initiated by Firm | October 29, 2007 |
Date Posted | April 08, 2008 |
Recall Status1 |
Terminated 3 on September 21, 2011 |
Recall Number | Z-0712-2008 |
Recall Event ID |
45503 |
510(K)Number | K062284 |
Product Classification |
Cranial Electrotherapy Stimulator - Product Code JXK
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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 |
Code Information |
Serial Numbers: 1000 through 3999. |
Recalling Firm/ Manufacturer |
Neuro-Fitness LLC 33631 #2 Redmond-Fall City Rd. Fall City WA 98024
|
For Additional Information Contact | Michael Stevens 425-821-4968 |
Manufacturer Reason for Recall | No FDA clearance for the .35Hz/.45Hz frequency option on device. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JXK
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