FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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.
Brand
Ortho Kinematics, Inc
UPC
00868579000209.

Units Affected

1