FDA recall Z-1627-2023

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

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

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