Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CS 9600

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall CS 9600 see related information
Date Initiated by Firm July 21, 2021
Date Posted May 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-1627-2023
Recall Event ID 92206
510(K)Number K181136  K200183  
Product Classification X-ray, tomography, computed, dental - Product Code OAS
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.¿
Code Information CS 9600
Recalling Firm/
Manufacturer		 Trophy SAS
Trophy Sas
Trophy; Croissy Beaubourg; 4 Rue Pelloutier
Marne La Vallee Cedex 2 France
For Additional Information Contact
033 164808526
Manufacturer Reason
for Recall		 Device failed to function as intended and/or failed to conform to their design specifications.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The letter identified the affected product, problem and actions to be taken.
Quantity in Commerce 895 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OAS and Original Applicant = Trophy
-
-