Recall of Device Recall Nebion HLX8 magnetic resonance

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nebion, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48967
  • Event Risk Class
    Class 1
  • Event Number
    Z-2464-2008
  • Event Initiated Date
    2008-06-25
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-01-10
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
  • Reason
    Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the fda.
  • 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.

Device

  • Model / Serial
    Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion HLX-8
  • Distribution
    Nationwide to CA, FL, HI, and RI.
  • Product Description
    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
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Nebion, LLC, 6060 Center Dr Ste 700, Los Angeles CA 90045-1587
  • Source
    USFDA