Neuro Kinetics VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
Brand
Neuro Kinetics
Lot Codes / Batch Numbers
Software versions 6.6 or earlier.
Products Sold
Software versions 6.6 or earlier.
Neuro Kinetics is recalling VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibul due to Marketed without a 510k or PMA submission to include the normative data display.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without a 510k or PMA submission to include the normative data display.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, FL, GA, HI, IN, MD, MA, MI, MN, NY, NC, OR, PA, SC, TN, UT, VA, WA, WV, DC
Page updated: Jan 10, 2026