Recall Z-2891-2018 ยท LLZ System, Image Processing, Radiological
Ortho Kinematics, Inc
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.
| Date | Mar 2, 2017 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Ortho Kinematics notified customers via telephone, email, and letter. Letter dated August 23, 2017 contained the following information: reason for notification, error report information, and requested acknowledgement of receipt. |
| 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 |