West Lake Hills, TX, United States
Ortho Kinematics, Inc recalls
4 recalls recorded since 2018, most recently on 23 May 2018. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)4
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 May 2018
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2889-2018
- Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
Ongoing Class II Medical devices
- Recall started
- 2 March 2017
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2891-2018
- 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.
Ongoing Class II Medical devices
- Recall started
- 11 January 2017
- Reason
- 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
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2882-2018
- 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.
Ongoing Class II Medical devices
- Recall started
- 12 August 2016
- Reason
- Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
- Distribution
- U.S. Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2890-2018
- Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.