Class 2 Device Recall IPortal Neuro Otologic Test Center

• Date Initiated by Firm: July 21, 2015
• Date Posted: September 03, 2015
• Recall Status: Terminated on September 27, 2016
• Recall Number: Z-2730-2015
• Recall Event ID: 71832
• 510(K)Number: K083603 K143607
• Product Classification: Nystagmograph - Product Code GWN
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Neuro Kinetics, Inc.; 128 Gamma Dr; Pittsburgh PA 15238-2920
• For Additional Information Contact: Customer Support; 412-963-6649
• Manufacturer Reason for Recall: The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
• FDA Determined Cause: No Marketing Application
• 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.
• Quantity in Commerce: 45
• Distribution: Worldwide Distribution - US (nationwide)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GWN; 510(K)s with Product Code = GWN