Recall Z-2889-2018 ยท LLZ System, Image Processing, Radiological
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
| Date | May 23, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Ortho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement. |
| Quantity | 1 |
| Distribution | U.S. Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133875 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA Ortho Kinematics, Inc., Jan 17, 2014 |