Trophy SAS recalls CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿de…

Recall date

July 21, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1627-2023

FDA classification

Class II

Brand / firm

Trophy SAS

Sold / distributed

Worldwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿and¿adult¿patients.¿