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Vertebral Motion Analyzer (VMA) Version 2.3.252 recallZ-2882-2018 · Ortho Kinematics, Inc · initiated Jan 11, 2017

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho Kinematics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Manufacturing/Software Deployment

What the company is doing

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.

Recall details

Recall number
Z-2882-2018
Status
Open, Classified
Initiated by the company
Jan 11, 2017
Recalling firm
Ortho Kinematics, Inc
Quantity
1
Product code
LLZ
FDA submissions
K133875
Distribution
US Nationwide Distribution

Product description

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.

Code information (models, lots, serial numbers)

UDI: 00868579000209

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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