Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VEST 6.6 or earlier software

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall VEST 6.6 or earlier software see related information
Date Initiated by Firm July 24, 2009
Date Posted September 30, 2009
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = NEURO KINETICS
-
-