Home / Recalls / Trophy SAS / Z-1627-2023

Z-1627-2023 Class II Ongoing

Recalled by Trophy SAS — Marne La Vallee Cedex 2, N/A

Recall Details

Product Type
Devices
Report Date
June 7, 2023
Initiation Date
July 21, 2021
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
895 units

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.

Distribution Pattern

Worldwide Distribution

Code Information

CS 9600

Other recalls by Trophy SAS

  • Z-1000-2013 Class II — CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (i (September 18, 2012)
  • Z-0999-2013 Class II — CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (in (September 18, 2012)
  • Z-1095-2013 Class II — CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expec (September 18, 2012)
  • Z-1094-2013 Class II — CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expec (September 18, 2012)