Class 1 Recall: Nebion, LLC HLX-8 Magnetic Resonance Device

Nebion HLX-8 Magnetic Resonance Device

This product was manufactured from December 25, 2006 through June 11, 2008, and distributed from June 1, 2007 through June 11, 2008.

The company’s labeling reported that the device 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 (PMS)
• rheumatoid arthritis
• ruptured disks
• shingles
• sports injuries and sprains

The firm has failed to provide FDA with any evidence to support these claims.

This device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.

Customers or other individuals that have been treated with the HLX8 device may contact Nebion, at 1-714-614-3141

On July 2, 2008, the company called each customer who purchased the device and:

• mailed the recall letter with a response form
• requested customers to complete the response form and to mail or FAX it back to the company
• instructed customers to immediately stop using the device
• requested the customers to contact Nebion to have the device picked up at the company’s expense by UPS
• instructed the customers to report any adverse reactions or problems experienced with the use of the product to FDA’s MedWatch Adverse Event Reporting program.

For more information about this recall, please see FDA's Press Release at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01925.html

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.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178