FDAClass IIAugust 29, 2018

Vertebral Motion Analyzer recall

Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to…

Why was Vertebral Motion Analyzer recalled?

Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.

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), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to…
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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