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U.S. Department of Health and Human Services

Class 2 Device Recall QuantumPulse machine

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  Class 2 Device Recall QuantumPulse machine see related information
Date Initiated by Firm October 01, 2008
Date Posted January 14, 2009
Recall Status1 Terminated 3 on May 03, 2012
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.
FDA Determined
Cause 2		 PMA
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.
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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