Events

Recall of Device Recall IPortal Neuro Otologic Test Center

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

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
    71832
  • Event Risk Class
    Class 2
  • Event Number
    Z-2730-2015
  • Event Initiated Date
    2015-07-21
  • Event Date Posted
    2015-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139176
  • 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
    Nystagmograph - Product Code GWN
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Product Description
    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.
  • Manufacturer Address
    Neuro Kinetics, Inc., 128 Gamma Dr, Pittsburgh PA 15238-2920
  • Manufacturer Parent Company (2017)
    Neuro Kinetics Inc.
  • Source
    USFDA