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Open, Classified

Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

FDA Recall Z-2891-2018 · Posted None

Recalling FirmOrtho Kinematics, Inc
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2017-03-02
Product Quantity1

Reason for Recall

Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.

Firm Action

Ortho Kinematics notified customers via telephone, email, and letter. Letter dated August 23, 2017 contained the following information: reason for notification, error report information, and requested acknowledgement of receipt.

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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