FDA recall Z-2882-2018

Product

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.

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2017-01-11

Report date

2018-08-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Lake Hills, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2882-2018