Recall Z-2882-2018— Ortho Kinematics, Inc

Name: FDA recall Z-2882-2018
Creator: U.S. Food and Drug Administration
Published: 2017-01-11

Class II · Ongoing

Class II FDA medical device recall by Ortho Kinematics, Inc, initiated 2017-01-11. It names one FDA 510(k) clearance: K133875. 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.. 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: Ortho Kinematics, Inc
Classification: Class II
Status: Ongoing
Initiated: 2017-01-11
Firm location: West Lake Hills, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K133875 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATAOrtho Kinematics, Inc.·cleared 2014-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.