Ortho Kinematics, Inc recalls Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative…

Recall date

August 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2890-2018

FDA classification

Class II

Brand / firm

Ortho Kinematics, Inc

Sold / distributed

U.S. Nationwide Distribution

Why it was recalled

Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vertebral 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.