FDAClass IIAugust 29, 2018

Vertebral Motion Analyzer recall: Software Issue

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Why was Vertebral Motion Analyzer recalled?

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.

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?

00868579000209

Product
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
Recalling firm
Ortho Kinematics, Inc
Quantity
1
Distribution
U.S. Nationwide Distribution
Recall date
August 29, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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