Recall Z-2882-2018 ยท LLZ System, Image Processing, Radiological
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
| Date | Jan 11, 2017 |
| Status | Open, Classified |
| Reason | Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Ortho Kinematics Inc sent notification to customers on 1/11/2017 via Letter and electronic notification through web app. The company deployed a software upgrade (VMA version 2.3.253) on January 11, 2017. |
| Quantity | 1 |
| Distribution | US 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 |