FDA recall Z-2889-2018

Product

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Reason for recall

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.

Distribution

U.S. Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2018-05-23

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-2889-2018