The FDA has notified healthcare professionals of a class I recall of the Nebion HLX-8 MR device because the device is not approved, lacked safety and effectiveness data and was not manufactured under current good manufacturing practices.
According to the FDA, The agency warned that “individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.”
The product was manufactured from Dec. 25, 2006 through June 11 of this year, and distributed from June 1, 2007 through June 11 of this year, according to the agency.
The FDA also said that the Los Angeles-based Nebion has failed to provide it with any evidence to support the marketing claims that the product could be used to treat many different medical conditions and diseases such as cancer, carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, sports injuries and sprains.
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, the agency said.