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FDA Medical Device Recalls (openFDA)

Ortho Kinematics, Inc: 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.

Recall number
Z-2890-2018
Recalling firm
Ortho Kinematics, Inc
Product
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.
Status
Open, Classified
Initiated
2016-08-12
Posted
not on file
Terminated
not on file
Reason
Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
Root cause
Software design
Action
Ortho Kinematics, Inc. notified customers via email dated August 19, 2016, Notice of Correction to VMA Results. The notification included the following information: reason for notice of correction, error information, and required action of 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
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z

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

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