Z-2891-2018 Class II Ongoing
FDA device recall Z-2891-2018 was initiated by Ortho Kinematics, Inc on March 2, 2017 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1.
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.