FDA-Device2023-06-07Class II
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.¿
Trophy SAS
Hazard
Device failed to function as intended and/or failed to conform to their design specifications.
Sold states
Worldwide Distribution
Affected count
895 units
Manufactured in
Trophy Sas, Trophy; Croissy Beaubourg; 4 Rue Pelloutier, Marne La Vallee Cedex 2, N/A, France
Products
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.¿
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1627-2023Don't want to check this manually?
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