FDA MedWatch

Nebion HLX-8 Magnetic Resonance Device: Device Not Approved By FDA

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.

Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Class I Recall notice regarding the above issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Nebion