Company: Ortho Kinematics, Inc
Date of Enforcement Report 8/29/2018
Class II:
PRODUCT
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. Recall Number: Z-2882-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Ortho Kinematics, Inc, West Lake Hills, TX on 1/11/2017 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
Nationwide