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U.S. Department of Health and Human Services

Medical Devices

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VIBE Technologies, Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Field Generator

Class 1 Recall
Date Recall
Initiated:
October 1, 2008
Product:

Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator

This product was manufactured and distributed from November 16, 2002 through March 19, 2008.

recall-100108

 

Use:

The company’s labeling reported that the device could be used to treat or cure medical conditions and diseases such as:

  • cancer
  • depression
  • infection
  • pain
The firm has failed to provide FDA with any evidence to support these claims.
Recalling Firm:
VIBE Technologies
2329 W. 10th St
Greeley, Colorado 80634-3527
Reason for Recall:
This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices.
Public Contact:
Customers or other individuals that have been treated with this device may contact VIBE Technologies at 1-970-356-9594.
FDA District:
Denver
FDA Comment:

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.

For more information about this recall, please see FDA's Press Release.

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.  See the nearby link to MedWatch.