Device product
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
Z-2889-2018
Product summary
- Event
- Event 80769
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-2889-2018
Official wording
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.
Code information: 00868579000209
Distribution pattern: U.S. Nationwide Distribution
Derived failure modes
-
Device software or design
software bug