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FDA Medical Device Recalls (openFDA)

Ortho Kinematics, Inc: Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.

Recall number
Z-2882-2018
Recalling firm
Ortho Kinematics, Inc
Product
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
Status
Open, Classified
Initiated
2017-01-11
Posted
not on file
Terminated
not on file
Reason
Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.
Root cause
Software Manufacturing/Software Deployment
Action
Ortho Kinematics Inc sent notification to customers on 1/11/2017 via Letter and electronic notification through web app. The company deployed a software upgrade (VMA version 2.3.253) on January 11, 2017.
Quantity
1
Distribution
US Nationwide Distribution
Lot, serial or model codes
UDI: 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

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