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Terminated

Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.

FDA Recall Z-0201-2009 · Posted 2008-11-03

Recalling FirmVIBE Technologies
Recall StatusTerminated
Date Initiated2008-10-01
Date Terminated2012-05-21
Product Quantity851 units

Reason for Recall

Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.

Firm 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.

Root Cause

PMA

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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