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Recall Observatory FDA recall evidence

Device product

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.

Z-2882-2018

January 11, 2017

Class II

Product summary

Firm
Ortho Kinematics, Inc
Event
Event 80680
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2882-2018

Official wording

Reason: 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.

Code information: UDI: 00868579000209

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software bug