Date Initiated by Firm |
October 01, 2008 |
Create Date |
January 14, 2009 |
Recall Status1 |
Terminated 3 |
Recall Number |
Z-0582-2009 |
Recall Event ID |
49609 |
Product |
QuantumPulse machine. Vibe Technologies, Greeley, CO.
The device is used to create light wave frequencies to effect cellular activity. |
Code Information |
All serial numbers. |
Recalling Firm/ Manufacturer |
VIBE Technologies 2329 W 10th St Greeley CO 80634-3527
|
For Additional Information Contact |
Gene Koonce 970-356-9594
|
Manufacturer Reason for Recall |
Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.
|
Action |
Customers were notified by letter on September 16, 2008 and were told to discontinue use as a medical device. This letter notification included:
1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such;
2. An updated operation manual/users guide containing no medical conditions or human body claims; and
3. A certification to be signed by the user and returned acknowledging receipt of the letter; affixed the warning label; will not promote the Quantum Pulse as a medical device; will remove any medical claims from their website; destroy any Quantum Pulse literature making medical claims and destroy any previous operation manual/user guides.
Please contact VIBE Technologies at 800-356-9594 for questions or need assistance in complying with these actions. |
Quantity in Commerce |
58 |
Distribution |
Worldwide Distribution. |
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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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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