Z-2253-2009

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

Name: Z-2253-2009 VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing
Creator: Neuro Kinetics
Published: 2009-07-24
License: https://open.fda.gov/license/

Spryson America Inc / initiated 2009-07-24 / Terminated

FDA source

Neuro Kinetics began a recall of VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing on 2009-07-24. The reason FDA records is "Marketed without a 510k or PMA submission to include the normative data display". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2253-2009
Status: Terminated
Initiated: 2009-07-24
Posted: 2009-09-30
Terminated: 2010-01-13
Recalling firm: Spryson America Inc
Product: VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
Product code: LXV Apparatus, Vestibular Analysis
Reason for recall: Marketed without a 510k or PMA submission to include the normative data display.
FDA 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 in commerce: 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.
Product codes and lots: Software versions 6.6 or earlier.

Product code LXV

K083603Class III-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (Vng), I-Portal Neuro OtolNeuro Kinetics / cleared 2009-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)