Device 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.¿
Z-1627-2023
Product summary
- Firm
- Trophy SAS
- Event
- Event 92206
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 895 units
- Official record key
device-enforcement:Z-1627-2023
Official wording
Reason: Device failed to function as intended and/or failed to conform to their design specifications.
Code information: CS 9600
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
Device failed to function as intended and/or failed to conform to their design specifications.