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Recall Observatory FDA recall evidence

Device product

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.

Z-2891-2018

March 02, 2017

Class II

Product summary

Firm
Ortho Kinematics, Inc
Event
Event 80771
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2891-2018

Official wording

Reason: 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.

Code information: 00868579000209.

Distribution pattern: U.S. Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.