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Open, Classified

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.

FDA Recall Z-2882-2018 · Posted None

Recalling FirmOrtho Kinematics, Inc
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2017-01-11
Product Quantity1

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.

Firm Action

Ortho Kinematics Inc sent notification to customers on 1/11/2017 via Letter and electronic notification through web app. The company deployed a software upgrade (VMA version 2.3.253) on January 11, 2017.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

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

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