FDA-Device2018-08-29Class II

Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

Ortho Kinematics, Inc
Hazard

Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

Sold states
U.S. Nationwide Distribution
Affected count
1
Manufactured in
110 Wild Basin Rd Ste 250, West Lake Hills, TX, United States
Products
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2890-2018

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