VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
Hazard
Marketed without a 510k or PMA submission to include the normative data display.
What You Should Do
Remedy
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.
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Products
VEST 6.6 or earlier software for use with Neuro Kinetics products.
The device is used for vestibular testing.
- Brand
- Neuro Kinetics
- UPC
- Software versions 6.6 or earlier.
Units Affected
72 units