FDA Enforcement
Class II
Ongoing
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.¿
Recall: Z-1627-2023
·
Reported June 7, 2023
Enforcement
- Recall Number
- Z-1627-2023
- Event ID
- 92206
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Trophy SAS
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- June 7, 2023
- Initiation Date
- July 21, 2021
- Classification Date
- May 26, 2023
- Address
- Trophy Sas, Trophy; Croissy Beaubourg; 4 Rue Pelloutier, Marne La Vallee Cedex 2, N/A, N/A, France
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.¿
Reason
Device failed to function as intended and/or failed to conform to their design specifications.
Code Info
CS 9600
Distribution
Worldwide Distribution
Quantity
895 units