FDA recall Z-2890-2018

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.

Reason for recall

Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

Distribution

U.S. Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2016-08-12

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-2890-2018