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U.S. Department of Health and Human Services

Class 1 Device Recall Nebion HLX8 magnetic resonance

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  Class 1 Device Recall Nebion HLX8 magnetic resonance see related information
Date Initiated by Firm June 25, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on January 10, 2011
Recall Number Z-2464-2008
Recall Event ID 48967
Product Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion H LX-8
Code Information Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion HLX-8
Recalling Firm/
Manufacturer		 Nebion, LLC
6060 Center Dr Ste 700
Los Angeles CA 90045-1587
For Additional Information Contact David LaPoint
714-614-3141
Manufacturer Reason
for Recall		 Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the FDA.
FDA Determined
Cause 2		 PMA
Action Nebion LLC contacted each holder of a device by telephone on July 2, 2008, and then mailed the recall letter titled URGENT MEDICAL DEVICE RECALL FOR NEBION HLX-8 by with attached recall response form. The customers were requested to completed the questionnaire (recall response form) and mail or fax it back to the company. The Letter instructed customers to stop using the device immediately and contact Nebion to have the device picked up at Nebion's expense by UPS. They were also instructed to report any 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 (information given regarding the FDA's MedWatch program). If you have questions, contact David LaPoint at 714-614-3141.
Quantity in Commerce 8
Distribution Nationwide to CA, FL, HI, and RI.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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