Brand
Trophy SAS
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Trophy SAS and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-06-07FDA-DeviceClass IICS¿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.¿
Device failed to function as intended and/or failed to conform to their design specifications.
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