Recall Z-2891-2018— Ortho Kinematics, Inc

Name: FDA recall Z-2891-2018
Creator: U.S. Food and Drug Administration
Published: 2017-03-02

Class II · Ongoing

Class II FDA medical device recall by Ortho Kinematics, Inc, initiated 2017-03-02. It names one FDA 510(k) clearance: K133875. Product: Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.. Reason: Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed..

Recalling firm: Ortho Kinematics, Inc
Classification: Class II
Status: Ongoing
Initiated: 2017-03-02
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), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

Reason for recall

Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.

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