FDAClass IIJune 7, 2023

CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two recall

CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nos…

Why was CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two recalled?

Device failed to function as intended and/or failed to conform to their design specifications.

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?

CS 9600

Product
CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nos…
Recalling firm
Trophy SAS
Quantity
895 units
Distribution
Worldwide Distribution
Recall date
June 7, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls