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U.S. Department of Health and Human Services

Safety

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Nebion HLX-8 Magnetic Resonance Device

Audience: Healthcare professionals, consumers

[Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

[December 15, 2008 - News Release - FDA]
[October 03, 2008 - Recall Notice - FDA]