Date Recall Initiated: |
October 1, 2008 |
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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. |
Use: |
The company’s labeling reported that the device could be used to treat or cure medical conditions and diseases such as:
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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:
For more information about this recall, please see FDA's Press Release at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01925.html 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.
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Updated December 18, 2008
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