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