Date Recall Initiated: |
June 25, 2008 |
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Product: |
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. |
Use: |
The company’s labeling reported that the device could be used to treat many different medical conditions and diseases such as:
The firm has failed to provide FDA with any evidence to support these claims. |
Recalling Firm: |
Nebion, LLC 6060 Center Drive, Suite 700 Los Angeles, California 90045 |
Reason for Recall: |
This device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. |
Public Contact: |
Customers or other individuals that have been treated with the HLX8 device may contact Nebion, at 1-714-614-3141 |
FDA District: |
Los Angeles |
FDA Comment: |
On July 2, 2008, the company called each customer who purchased the device and:
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.
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Updated December 18, 2008
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