Nebion HLX-8 Magnetic Resonance Device Recalled by FDA

Device Not FDA-Approved

The FDA has issued a class I recall of the Nebion HLX-8 Magnetic Resonance Device. The device was manufactured from December 25, 2006 through June 11, 2008, and distributed from June 1, 2007 through June 11, 2008.

According to the product's labelling, it can be used to treat cancer, carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptered disks, shingles, and sports injuries and sprains. However, the company has not provided evidence to the FDA to support these claims. Further, the device was not approved by the FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.

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Published on Oct-6-08