Recall Z-1627-2023— Trophy SAS
Class II · Ongoing
Class II FDA medical device recall by Trophy SAS, initiated 2021-07-21. It names 2 FDA 510(k) clearances: K200183, K181136. 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.¿. Reason: Device failed to function as intended and/or failed to conform to their design specifications..
- Recalling firm
- Trophy SAS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-07-21
- Firm location
- Marne La Vallee Cedex 2, N/A, France
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.