The company’s labeling reported that the device could be used to treat or cure medical conditions and diseases such as:
The firm as failed to provide FDA with any evidence to support these claims.
On October 1, 2008, the company sent a certified letter to each customer who purchased the device to stop using it. 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/users’ guide that contains no medical conditions or treatment claims.
- 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, and
- understand that the VIBE Machine does not affect the structure or function of the human or animal body.
- a request that the user certify that they will:
- not promote the VIBE Machine as a medical device.
- remove any medical claims from their individual websites, and
- destroy any VIBE literature making medical claims.
- a warning that failure to sign and return the certification will result in the company refusing to service their machine.
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.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
This page was posted on November 4, 2008.