Trophy SAS: Medical Device Recall in 2023 - (Recall #: Z-1627-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.¿

Product Classification:

Class II

Date Initiated: July 21, 2021

Date Posted: June 7, 2023

Recall Number: Z-1627-2023

Event ID: 92206

Reason for Recall:

Device failed to function as intended and/or failed to conform to their design specifications.

Status: Ongoing

Product Quantity: 895 units

Code Information:

CS 9600

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

FDA Mandated