Events

Rappel de Device Recall Nebion HLX8 magnetic resonance

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Nebion, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    48967
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2464-2008
  • Date de mise en oeuvre de l'événement
    2008-06-25
  • Date de publication de l'événement
    2008-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72426
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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

Device Recall Nebion HLX8 magnetic resonance
  • Modèle / numéro de série
    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.
  • Description du dispositif
    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
    Nebion, LLC

Manufacturer

Nebion, LLC
  • Adresse du fabricant
    Nebion, LLC, 6060 Center Dr Ste 700, Los Angeles CA 90045-1587
  • Source
    USFDA