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

Recalled June 7, 2023 · FDA recall Z-1627-2023 · Trophy SAS

Hazard

Device failed to function as intended and/or failed to conform to their design specifications. · FDA Class II

Units

895 units

Sold at

Worldwide Distribution

Description

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

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,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿and¿adult¿patients.¿

Manufacturer(s)

Trophy SAS

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →