Nebion recall
This article was originally published in The Gray Sheet
Executive Summary
FDA recalls Nebion's HLX-8 magnetic resonance device, which the company claimed can treat medical conditions such as cancer, carpel tunnel syndrome, migraines, arthritis and certain injuries, but is not FDA approved. Nebion "failed to provide FDA with any evidence to support these claims," FDA writes in an Oct. 3 Class I recall notice. On July 2, Nebion notified customers about the recall and instructed them to stop using the device and to report any adverse reactions or problems to FDA