Recall – Ortho Kinematics Vertebral Motion Analyzer Cl II

Company:Ortho Kinematics, Inc
Date of Enforcement Report 8/29/2018
Class lI:

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.
Recall Number: Z-2882-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Ortho Kinematics, Inc, West Lake Hills, TX on 1/11/2017 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
Nationwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Recall – Ortho Kinematics Vertebral Motion Analyzer Cl II

Amy Sellers

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