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U.S. Department of Health and Human Services

Class 2 Device Recall Vertebral Motion Analyzer

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  Class 2 Device Recall Vertebral Motion Analyzer see related information
Date Initiated by Firm January 11, 2017
Create Date August 21, 2018
Recall Status1 Open3, Classified
Recall Number Z-2882-2018
Recall Event ID 80680
510(K)Number K133875  
Product Classification System, image processing, radiological - Product Code LLZ
Product Vertebral Motion Analyzer (VMA) Version 2.3.252.

VMA software is a quantitative imaging software application intended to be used to process digital image files.
Code Information UDI: 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 Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Ortho Kinematics Inc sent notification to customers on 1/11/2017 via Letter and electronic notification through web app. The company deployed a software upgrade (VMA version 2.3.253) on January 11, 2017.
Quantity in Commerce 1
Distribution US 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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