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U.S. Department of Health and Human Services

Class 2 Device Recall THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2

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  Class 2 Device Recall THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2 see related information
Date Initiated by Firm March 02, 2017
Create Date August 22, 2018
Recall Status1 Open3, Classified
Recall Number Z-2891-2018
Recall Event ID 80771
510(K)Number K133875  
Product Classification System, image processing, radiological - Product Code LLZ
Product Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254.

Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
Code Information 00868579000209.
Recalling Firm/
Manufacturer		 Ortho Kinematics, Inc
110 Wild Basin Rd Ste 250
West Lake Hills TX 78746-3352
For Additional Information Contact
512-334-5490
Manufacturer Reason
for Recall		 Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.
FDA Determined
Cause 2		 Software design
Action Ortho Kinematics notified customers via telephone, email, and letter. Letter dated August 23, 2017 contained the following information: reason for notification, error report information, and requested acknowledgement of receipt.
Quantity in Commerce 1
Distribution U.S. Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = ORTHO KINEMATICS, INC.
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