Class 1 Recall For VIBE Technologies and Nebion Unapproved Medical Devices – The U.S. Food and Drug Administration (FDA) has announced a Class 1 recall for two unapproved and uncleared medical devices manufactured by VIBE Technologies of Greeley, CO, and Nebion, LLC of Los Angeles, CA.
Both manufacturers made claims that their products treated serious and life-threatening illnesses, including cancer, depression, infections, migraines, arthritis, and ruptured discs. Neither company had submitted an application to the FDA for clinical trials that would demonstrate that these products safely and effectively treated these conditions.
Subject to recall are:
• Vibrational Integrated Bio-photonic Energizer (VIBE device); manufactured by VIBE Technologies and claims to treat cancer, infections, and depression.
• HLX8 device, manufactured by Nebion, LLC, and claims to treat cancer, migraines, arthritis, and ruptured discs.
FDA Class 1 Recall
A Class 1 recall means that there is a reasonable probability that the use of the recalled medical device will cause adverse health consequences or death. In the cases of VIBE Technologies and Nebion, LLC, the FDA is concerned that based on the unapproved health claims made by both companies, patients will not seek approved therapies, resulting in more severe illness or death.
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Reporting Adverse Events to the FDA: Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
• Online: Medwatch Safety Reporting
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088
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