CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.
This recall is currently active, issued May 27, 2023. It was issued by Trophy Sas Trophy Sas Trophy; Croissy Beaubourg.
- Recall Initiated
- July 21, 2021
- Posted
- May 27, 2023
- Recall Number
- Z-1627-2023
- Quantity
- 895 units
- Official Source
- View on FDA website ↗
Reason for Recall
Device failed to function as intended and/or failed to conform to their design specifications.
Distribution
Worldwide Distribution
Lot / Code Info
CS 9600
Root Cause
Radiation Control for Health and Safety Act
Action Taken
The letter identified the affected product, problem and actions to be taken.