Z-2464-2008

Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If...

Name: Z-2464-2008 Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If...
Creator: Nebion, LLC
Published: 2008-06-25
License: https://open.fda.gov/license/

Nebion, LLC / initiated 2008-06-25 / Terminated / root cause: labeling and UDI

FDA source

Nebion, LLC began a recall of 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 on 2008-06-25. The reason FDA records is "Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the FDA". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2464-2008
Status: Terminated
Initiated: 2008-06-25
Posted: 2008-09-20
Terminated: 2011-01-10
Recalling firm: Nebion, LLC
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
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion HLX-8

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)