Ortho Kinematics, Inc recalls Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended t…

Recall date

January 11, 2017

Source

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

Recall number

Z-2882-2018

FDA classification

Class II

Brand / firm

Ortho Kinematics, Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

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) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.