FDA Medical Device Recalls (openFDA)
Ortho Kinematics, Inc: Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
- Recall number
- Z-2889-2018
- Recalling firm
- Ortho Kinematics, Inc
- Product
- Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
- Status
- Open, Classified
- Initiated
- 2018-05-23
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- Ortho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement.
- 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