Home / Recalls / Ortho Kinematics, Inc / Z-2882-2018

Z-2882-2018 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 29, 2018
Initiation Date
January 11, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.

Reason for Recall

Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.

Distribution Pattern

US Nationwide Distribution

Code Information

UDI: 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-2891-2018 Class II — Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA softw (March 2, 2017)
  • Z-2890-2018 Class II — Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Pro (August 12, 2016)