Trophy SAS Recall 92206
Description: 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 Recall 92206 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1627-2023 |
| Event ID | 92206 |
| Event Description | 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.¿ |
| Product Type | Devices |
| Distribution | Worldwide Distribution |
| Quantity | 895 units |
| Recall Reason | Device failed to function as intended and/or failed to conform to their design specifications. |
| Device Classification | 20230607 |
| Device Code Info | CS 9600 |
| Center Classification Date | 20230526 |
| Recall Initiation Date | 20210721 |
| Recalling Firm | Trophy SAS |
| Initial Notification | Letter |
| Similar To |