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Class 1 Device Recall VIBE |
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Date Initiated by Firm |
October 01, 2008 |
Date Posted |
November 03, 2008 |
Recall Status1 |
Terminated 3 on May 21, 2012 |
Recall Number |
Z-0201-2009 |
Recall Event ID |
49590 |
Product |
Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer. |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
VIBE Technologies 2329 W 10th St Greeley CO 80634-3527
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For Additional Information Contact |
Gene Koonce 970-356-9594
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Manufacturer Reason for Recall |
Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.
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FDA Determined Cause 2 |
PMA |
Action |
Vibe 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 Commerce |
851 units |
Distribution |
Worldwide |
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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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