FDA Device

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.

Hazard

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.

What You Should Do

Remedy

Ortho Kinematics Inc sent notification to customers on 1/11/2017 via Letter and electronic notification through web app. The company deployed a software upgrade (VMA version 2.3.253) on January 11, 2017.

Products

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.
Brand
Ortho Kinematics, Inc
UPC
UDI: 00868579000209

Units Affected

1