The US Food and Drug Administration (FDA) has posted information about a recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator, which was not approved by the FDA. The agency indicates it was not made under current good manufacturing practices.
The device was marketed and sold between November 2002 and March 2008 with statements that it could be used to treat or cure cancer, depression, infection and general pain. However, the FDA has never determined that the VIBE machine is safe or effective, as no data has been provided by the manufacturer to support these claims.
The FDA categorized the VIBE recall as a “Class 1 Recall”, which is the most serious type, reserved for situations where there is a reasonable probability that the use of the product will cause serious injury or death.
In addition to issuing the VIBE machine recall, the FDA has urged consumers and health-care professionals to report any incidents of adverse reactions or quality problems that have been associated with the use of this product. Reports can be submitted on-line through the FDA MedWatch Reporting program.
Vibe Technologies, which is based in Colorado, is cooperating with the FDA’s recall. Certified letters will be sent to all consumers who purchased the Vibe Machine, advising them to immediately stop using the device.
The letter also includes a new warning label which clearly indicates that the VIBE machine is not a medical device and should not be used as one, an updated users guide that contains no medical claims and a certification to be signed by the owner confirming they received the notice and understand that the VIBE machine does not affect the structure or function of the human body.
Many of the VIBE machines have been sold to clinics or individuals who may still be promoting the machine as a medical device for treatment of cancer, depression, infection or pain.
Tags: Vibe Machine