FDAClass IIApril 24, 2013

DeGotzen XRay unit XGenus Dental X-ray unit recall: Labeling Error

DeGotzen XRay unit XGenus Dental X-ray unit.

Why was DeGotzen XRay unit XGenus Dental X-ray unit recalled?

It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

766471

Product
DeGotzen XRay unit XGenus Dental X-ray unit.
Recalling firm
DeGotzen
Quantity
159 units
Distribution
US (nationwide)
Recall date
April 24, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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