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U.S. Department of Health and Human Services

Class 1 Device Recall VIBE

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 Class 1 Device Recall VIBEsee related information
Date Initiated by FirmOctober 01, 2008
Date PostedNovember 03, 2008
Recall Status1 Terminated 3 on May 21, 2012
Recall NumberZ-0201-2009
Recall Event ID 49590
ProductVibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.
Code Information All serial numbers
FEI Number 3004494240
Recalling Firm/
Manufacturer		 VIBE Technologies
2329 W 10th St
Greeley CO 80634-3527
For Additional Information ContactGene Koonce
970-356-9594
Manufacturer Reason
for Recall		Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.
FDA Determined
Cause 2		PMA
ActionVibe Technologies notified their customers by letter on October 1, 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. 3. A certification to be signed by the user and returned acknowledging that they: received the letter; affixed the warning label to the Vibe machine; understand that the Vibe machine does not affect the structure/function of the human or animal body; will not promote the Vibe machine as a medical device; will remove any medical claims from their website; destroy any Vibe literature making medical claims. Approximately three weeks after the certified mailing, the firm will begin performing recall effectiveness checks.
Quantity in Commerce851 units
DistributionWorldwide
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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