Class 2 Device Recall CS 9600

• Date Initiated by Firm: July 21, 2021
• Date Posted: May 27, 2023
• Recall Status: Open, 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: CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.
• Code Information: CS 9600
• FEI Number: 7695
• 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: 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