FDA Announces Class 1 Recall of Unapproved MR DeviceFDA 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.