# FDA recall Z-1627-2023

> **Trophy SAS** · Class II · device recall initiated 2021-07-21.

## 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.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-1627-2023
- **Recalling firm:** Trophy SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-21
- **Report date:** 2023-06-07

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Marne La Vallee Cedex 2, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1627-2023

## Citation

> AI Analytics. FDA recall Z-1627-2023. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1627-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*