Ortho Kinematics, Inc recalls Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Recall date

May 23, 2018

Source

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

Recall number

Z-2889-2018

FDA classification

Class II

Brand / firm

Ortho Kinematics, Inc

Sold / distributed

U.S. Nationwide Distribution

Why it was recalled

This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.

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), 2.3.250. Product System, image processing, radiological