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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 2.2see related information
Date Initiated by FirmAugust 12, 2016
Create DateAugust 22, 2018
Recall Status1 Open3, Classified
Recall NumberZ-2890-2018
Recall Event ID 80768
510(K)NumberK133875 
Product Classification System, image processing, radiological - Product Code LLZ
ProductVertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
Code Information 00868579000209
FEI Number 3006172536
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. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
FDA Determined
Cause 2		Software design
ActionOrtho Kinematics, Inc. notified customers via email dated August 19, 2016, Notice of Correction to VMA Results. The notification included the following information: reason for notice of correction, error information, and required action of acknowledgement.
Quantity in Commerce1
DistributionU.S. Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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