Recall Z-1627-2023 ยท OAS X-Ray, Tomography, Computed, Dental
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CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.
| Date | May 27, 2023 (initiated Jul 21, 2021) |
| Status | Open, Classified |
| Reason | Device failed to function as intended and/or failed to conform to their design specifications. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The letter identified the affected product, problem and actions to be taken. |
| Quantity | 895 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |