Recall Z-2889-2018— Ortho Kinematics, Inc

Name: FDA recall Z-2889-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-23

Class II · Ongoing

Class II FDA medical device recall by Ortho Kinematics, Inc, initiated 2018-05-23. It names one FDA 510(k) clearance: K133875. Product: Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological. Reason: This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error..

Recalling firm: Ortho Kinematics, Inc
Classification: Class II
Status: Ongoing
Initiated: 2018-05-23
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), 2.3.250. Product System, image processing, radiological

Reason for recall

This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.

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