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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

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-1627-2023
Event ID92206
Event DescriptionCS¿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 TypeDevices
DistributionWorldwide Distribution
Quantity895 units
Recall ReasonDevice failed to function as intended and/or failed to conform to their design specifications.
Device Classification20230607
Device Code InfoCS 9600
Center Classification Date20230526
Recall Initiation Date20210721
Recalling FirmTrophy SAS
Initial Notification Letter
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