FDA Medical Device Recalls (openFDA)
Neuro Kinetics: VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
- Recall number
- Z-2253-2009
- Recalling firm
- Neuro Kinetics
- Product
- VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
- Status
- Terminated
- Initiated
- 2009-07-24
- Posted
- 2009-09-30
- Terminated
- 2010-01-13
- 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.
- Lot, serial or model codes
- Software versions 6.6 or earlier.
- 510(k) numbers
- ["K083603"]
- PMA numbers
- not on file
- Product code
- LXV
- Firm FEI
- 2519945
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28