Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-2889-2018 · Posted None

Recalling FirmOrtho Kinematics, Inc
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2018-05-23
Product Quantity1

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.

Firm Action

Ortho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement.

Root Cause

Software design

Distribution Pattern

U.S. Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑