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.
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
