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

FDA device recall Z-0582-2009 · posted 2009-01-14 · Terminated

Recall details

Recalling firm

VIBE Technologies

Reason for recall

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

Action taken

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

Status

Terminated

Quantity affected

58

Distribution

Worldwide Distribution.

Date initiated

2008-10-01

Date posted

2009-01-14

Date terminated

2012-05-03

Location

Greeley, CO