Nebion, LLC 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Nebion, LLC
Lot Codes / Batch Numbers
Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion HLX-8
Products Sold
Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion HLX-8
Nebion, LLC is recalling Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no lab due to Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the FDA.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the FDA.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026