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Open, Classified

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.

FDA Recall Z-2890-2018 · Posted None

Recalling FirmOrtho Kinematics, Inc
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2016-08-12
Product Quantity1

Reason for Recall

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

Firm Action

Ortho Kinematics, Inc. notified customers via email dated August 19, 2016, Notice of Correction to VMA Results. The notification included the following information: reason for notice of correction, error information, and required action of 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.

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