FDA Announces Class 1 Recall of Unapproved MR Device

The FDA has notified healthcare professionals of a Class 1 recall of the Nebion HLX-8 MR device because the device is not approved, healthimaging.com reports. The agency also said that the product, made by Nebion of Los Angeles, lacks safety and effectiveness data and was not manufactured under GMP standards. The device was made between December 2006 and June 2008.

October 7, 2008

1 Min Read
FDA Announces Class 1 Recall of Unapproved MR Device

Practitioners should stop using the device and contact Nebion to arrange its return, the agency says.The company claimed in marketing materials that the product could treat everything from cancer to shingles to sports injuries. None of those claims are supported by any data, the agency says.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like