FDA Medical Device Recalls (openFDA)
Ortho Kinematics, Inc: 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.
- Recall number
- Z-2891-2018
- Recalling firm
- Ortho Kinematics, Inc
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2017-03-02
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- Ortho Kinematics notified customers via telephone, email, and letter. Letter dated August 23, 2017 contained the following information: reason for notification, error report information, and requested acknowledgement of receipt.
- Quantity
- 1
- Distribution
- U.S. Nationwide Distribution
- Lot, serial or model codes
- 00868579000209.
- 510(k) numbers
- ["K133875"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3006172536
- Firm city
- West Lake Hills
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28