Z-2890-2018 Class II Ongoing
FDA device recall Z-2890-2018 was initiated by Ortho Kinematics, Inc on August 12, 2016 and is designated Class II. Reason for recall: Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected. The recall status is ongoing. Affected quantity: 1.
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