Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0582-2009

QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create light wave frequencies to...

VIBE Technologies / initiated 2008-10-01 / Terminated

VIBE Technologies began a recall of QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create light wave frequencies to effect cellular activity on . The reason FDA records is "Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0582-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
VIBE Technologies
Product
QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create light wave frequencies to effect cellular activity.
Reason for recall
Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.
FDA root cause
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.
Product codes and lots
All serial numbers.