Events

Rappel de Device Recall IPortal Neuro Otologic Test Center

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 Neuro Kinetics, Inc..

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
    71832
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2730-2015
  • Date de mise en oeuvre de l'événement
    2015-07-21
  • Date de publication de l'événement
    2015-09-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139176
  • 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
    Nystagmograph - Product Code GWN
  • Cause
    The devices that included the ovar research test were not cleared for marketing and mtbi research package was sold with the incorrect investigational label.
  • Action
    Neuro Kinetics sent notification letters to end users on/about July 24, 2015, to alert them to the reason for recall and inform them of the corrective action planned by Neurokinetics. Action to be taken by you the Customer/User: If you have already initiated OVAR research (an IRB approved study with non-significant risk designation is ongoing), please reply to this email and include a copy of the IRB approval letter or the IRB approval information (e.g., investigators name, IRB name, IRB location, and study reference number). In return, NKI will mail you a field correction package with the necessary and appropriate Investigational Device labeling. If you have not initiated OVAR research (an IRB approved study is not ongoing), please discontinue use of the OVAR test and reply to this email to confirm that you are not using the OVAR test as part of an IRB approved study. In return, NKI will mail you a field correction package to disable the OVAR test functionality, which can be restored at the time you have an IRB approved study. Disabling the OVAR research test will have no effects on the functionality of the clinical tests included with your NOTC system. There will be no perceivable changes to the system outside of not being able to run the OVAR test. For questions regarding this recall call 412-963-6649.

Device

Device Recall IPortal Neuro Otologic Test Center
  • Modèle / numéro de série
    models: I-Portal¿ NOTC-O I-Portal¿ NOTC-C,   with S/N 890739 S/N 900140 S/N 900133 S/N 900114 S/N 900172 S/N 900136 S/N 900162 S/N 900134 S/N 900137 S/N 900147 S/N 890739 S/N 900140 S/N 900169 S/N 890738 S/N 900133 S/N 900118 S/N 900127 S/N 900138 S/N 900163 S/N 890742 S/N 890773 S/N 900155 S/N 900150 S/N 900158 S/N 900125 S/N 900123 S/N 900108 S/N 900114 S/N 900160 S/N 900168 S/N 900102 S/N 900130 S/N 900131 S/N 900128 S/N 900144 S/N 890741 S/N 890726 S/N 890736 S/N 900145 S/N 900111 S/N 900119
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Description du dispositif
    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
  • Manufacturer
    Neuro Kinetics, Inc.

Manufacturer

Neuro Kinetics, Inc.
  • Adresse du fabricant
    Neuro Kinetics, Inc., 128 Gamma Dr, Pittsburgh PA 15238-2920
  • Société-mère du fabricant (2017)
    Neuro Kinetics Inc.
  • Source
    USFDA