Z-2890-2018 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 29, 2018
Initiation Date
August 12, 2016
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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.

Reason for Recall

Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

Distribution Pattern

U.S. Nationwide Distribution

Code Information

00868579000209