Federal regulators have issued another Class I recall for an <"https://www.yourlawyer.com/practice_areas/defective_drugs">unapproved medical device.Â This time, the Food & Drug Administration (FDA) has recalled the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado.Â Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
On its website, Vibe Technologies claims that the VIBE Machine ” increases your inner-connectively to your DNA, giving it what it needs to balance itself. This machine is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level”.Â However, the FDA says that that the VIBE Machine is not approved, and that the company’s claims that it can be used to treat or cure medical conditions and diseases such as cancer, depression, infection, and pain are unproven.
In April 2008, the FDA issued a warning letter to VIBE Technologies following an inspection of its Colorado headquarters in November 2007.Â This inspection revealed that the company had not obtained marketing approval or clearance before it began offering the VIBE machine for sale, which is a violation of the law.Â The inspection also revealed that the device was adulterated within the meaning of the Food, Drug & Cosmetic Act in that the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation were not in conformity withÂ Current Good Manufacturing PracticeÂ requirements of the Quality System regulation.
VIBE Machines affected by this recall were soldÂ between November 2002 and March 2008.Â According to the FDA, On October 1, 2008, the company sent a certified letter to each customer who purchased the device advising them to stop using the VIBE machine.Â The letter also included a warning label to be permanently placed on the VIBE Machine stating that it is not a medical device and should not be used as one; an updated operation manual/usersâ€™ guide that contains no medical conditions or treatment claims; and a certification to be signed by the user and returned to the company acknowledging that they received the letter, attached the warning label on the device, andÂ understand that the VIBE Machine does not affect the structure or function of the human or animal body.
Users have also been asked to certify that they will not promote the VIBE Machine as a medical device. In addition, users of the Vibe Machine have been directed to remove any medical claims from their individual websites, and destroy any VIBE literature making medical claims. Finally, users of the VIBE machine have been warned that failure to sign and return the certification will result in the company refusing to service their machine.