FDAClass IIMay 1, 2019

cone-beam CT system recall

cone-beam CT system

Why was cone-beam CT system recalled?

ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

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?

versions 2.1.0 and 2.1.1

Product
cone-beam CT system
Recalling firm
KaVo Dental Technologies LLC
Quantity
230
Distribution
US distribution in NC
Recall date
May 1, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls