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.¿
Reported: June 7, 2023 Initiated: July 21, 2021 #Z-1627-2023
Product 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 for Recall
Device failed to function as intended and/or failed to conform to their design specifications.
Details
- Recalling Firm
- Trophy SAS
- Units Affected
- 895 units
- Distribution
- Worldwide Distribution
- Location
- Marne La Vallee Cedex 2, N/A
Frequently Asked Questions
What product was recalled? ▼
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.¿. Recalled by Trophy SAS. Units affected: 895 units.
Why was this product recalled? ▼
Device failed to function as intended and/or failed to conform to their design specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 7, 2023. Severity: Moderate. Recall number: Z-1627-2023.
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