Home / Recalls / Ortho Kinematics, Inc / Z-2891-2018

Z-2891-2018 Class II Ongoing

Recalled by Ortho Kinematics, Inc — West Lake Hills, TX

Recall Details

Product Type
Devices
Report Date
August 29, 2018
Initiation Date
March 2, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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.

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 Pattern

U.S. Nationwide Distribution

Code Information

00868579000209.

Other recalls by Ortho Kinematics, Inc

  • Z-2889-2018 Class II — Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, r (May 23, 2018)
  • Z-2882-2018 Class II — Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitat (January 11, 2017)
  • Z-2890-2018 Class II — Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Pro (August 12, 2016)