CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and… — Class II medical device recall Z-1627-2023
Ongoing recall by Trophy SAS, reported 2023-06-07. Device failed to function as intended and/or failed to conform to their design specifications.
| Recall number | Z-1627-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Trophy SAS, Marne La Vallee Cedex 2, N/A, France |
| Recall initiated | 2021-07-21 |
| Classified | 2023-05-26 |
| Reported by FDA | 2023-06-07 |
| Quantity | 895 units |
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 for recall
Device failed to function as intended and/or failed to conform to their design specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1627-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.