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.
- Company
- Ortho Kinematics, Inc
- Recall Initiated
- March 2, 2017
- Recall Number
- Z-2891-2018
- Quantity
- 1
- Firm Location
- West Lake Hills, TX
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.
Distribution
U.S. Nationwide Distribution
Lot / Code Info
00868579000209.
Root Cause
Software design
Action Taken
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.
More recalls by Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), 2.3.250.
Product System, image processing, radiological
May 23, 2018