FDA Device

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Hazard

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.

What You Should Do

Remedy

Ortho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement.

Products

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
Brand
Ortho Kinematics, Inc
UPC
00868579000209

Units Affected

1