Recall Z-2890-2018 ยท LLZ System, Image Processing, Radiological
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
| Date | Aug 12, 2016 |
| Status | Open, Classified |
| Reason | Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected. |
| Root cause | Software design |
| Action | Ortho Kinematics, Inc. notified customers via email dated August 19, 2016, Notice of Correction to VMA Results. The notification included the following information: reason for notice of correction, error information, and required action of 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 |