Class 2 Device Recall VEST 6.6 or earlier software

• Date Initiated by Firm: July 24, 2009
• Date Posted: September 30, 2009
• Recall Status: Terminated on January 13, 2010
• Recall Number: Z-2253-2009
• Recall Event ID: 52961
• 510(K)Number: K083603
• Product Classification: VEST 6.6 or earlier software - Product Code LXV
• Product: VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
• Code Information: Software versions 6.6 or earlier.
• FEI Number: 2519945
• Recalling Firm/ Manufacturer: Neuro Kinetics; 128 Gamma Dr; Pittsburgh PA 15238-2920
• For Additional Information Contact: Joe Argyros; 412-963-6649
• Manufacturer Reason for Recall: Marketed without a 510k or PMA submission to include the normative data display.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = LXV