FDAClass IIAugust 29, 2018

Vertebral Motion Analyzer recall: Software Issue

Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital…

Why was Vertebral Motion Analyzer 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 00868579000209

Product
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital…
Recalling firm
Ortho Kinematics, Inc
Quantity
1
Distribution
US Nationwide Distribution
Recall date
August 29, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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