Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
This recall is currently active, issued May 23, 2018. It was issued by Ortho Kinematics, Inc.
- Company
- Ortho Kinematics, Inc
- Recall Initiated
- May 23, 2018
- Recall Number
- Z-2889-2018
- Quantity
- 1
- Firm Location
- West Lake Hills, TX
- Official Source
- View on FDA website ↗
Reason for Recall
This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
Distribution
U.S. Nationwide Distribution
Lot / Code Info
00868579000209
Root Cause
Software design
Action Taken
Ortho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement.
More recalls by Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254.
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Mar 2, 2017