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Terminated

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

FDA Recall Z-0582-2009 · Posted 2009-01-14

Recalling FirmVIBE Technologies
Recall StatusTerminated
Date Initiated2008-10-01
Date Terminated2012-05-03
Product Quantity58

Reason for Recall

Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.

Firm 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.

Root Cause

PMA

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

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

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