Recall Z-2253-2009
Neuro Kinetics · initiated July 24, 2009
Product
VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
Codes / lots: Software versions 6.6 or earlier.
Reason for recall
Marketed without a 510k or PMA submission to include the normative data display.
FDA-determined cause: PMA
Action taken
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.
Details
- Recall number
- Z-2253-2009
- Initiated
- July 24, 2009
- Posted by FDA
- September 30, 2009
- Terminated
- January 13, 2010
- Product code
- LXV – Apparatus, Vestibular Analysis
- 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.
- Recalling firm
- Neuro Kinetics, Pittsburgh, PA