Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.

FDA device recall Z-0201-2009 · posted 2008-11-03 · Terminated

Recall details

Recalling firm

VIBE Technologies

Reason for recall

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

Action taken

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

Status

Terminated

Quantity affected

851 units

Distribution

Worldwide

Date initiated

2008-10-01

Date posted

2008-11-03

Date terminated

2012-05-21

Location

Greeley, CO