Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0201-2009

Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer

VIBE Technologies / initiated 2008-10-01 / Terminated

VIBE Technologies began a recall of Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer on . The reason FDA records is "Medical device marketed without marketing approval for claims that include cures cancer, infections, depression". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0201-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
VIBE Technologies
Product
Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.
Reason for recall
Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.
FDA root cause
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
Product codes and lots
All serial numbers