Beijing Economic & Technological Develop, CN · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | 2 | 2024-02-22 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-11-07 | Class II | Ongoing | Z-0553-2024 | The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator… | — | GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products wh… |
| 2023-11-07 | Class II | Ongoing | Z-0552-2024 | The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator… | — | GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products wh… |