Recall Z-2253-2009 ยท LXV Apparatus, Vestibular Analysis
Neuro Kinetics
VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
| Date | Sep 30, 2009 (initiated Jul 24, 2009) |
| Status | Terminated |
| Reason | Marketed without a 510k or PMA submission to include the normative data display. |
| Root cause | PMA |
| Action | A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance. Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649. |
| Quantity | 72 units |
| Distribution | Worldwide Distribution -- US (states of AL, AZ, CA, DC, FL, GA, HI, IN, MA, MD, MI, MN, NC, NY, OR, PA, SC, TN, UT, VA, WA, and WV), Korea, United Kingdom, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL Neuro Kinetics, Aug 6, 2009 |