FDA recall Z-2891-2018

Product

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.

Reason for recall

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.

Distribution

U.S. Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2017-03-02

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-2891-2018