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Terminated

VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.

FDA Recall Z-2253-2009 · Posted 2009-09-30

Recalling FirmNeuro Kinetics
Recall StatusTerminated
Product CodeLXV
Date Initiated2009-07-24
Date Terminated2010-01-13
Product Quantity72 units

Reason for Recall

Marketed without a 510k or PMA submission to include the normative data display.

Firm 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.

Root Cause

PMA

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083603I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOLNeuro Kinetics · 2009-08-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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