Ortho Kinematics, Inc recalls Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software appl…

Recall date

March 2, 2017

Source

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

Recall number

Z-2891-2018

FDA classification

Class II

Brand / firm

Ortho Kinematics, Inc

Sold / distributed

U.S. Nationwide Distribution

Why it was recalled

Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.

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), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.