Device product
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.
Z-2890-2018
Product summary
- Event
- Event 80768
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-2890-2018
Official wording
Reason: Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
Code information: 00868579000209
Distribution pattern: U.S. Nationwide Distribution
Derived failure modes
-
Device software or design
software bug