Device product
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
Z-2152-2017
Product summary
- Event
- Event 76808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 systems
- Official record key
device-enforcement:Z-2152-2017
Official wording
Reason: During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. This footswitch is actively involved in the safety circuit of the urological table. Only if footswitch + exposure + first primary barrier are closed the signal will be transmitted to the generator for activating X-ray. During intended use only with this footswitch X-ray should be activated.
Code information: model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. This footswitch is actively involved in the safety circuit of the urological table. Only if footswitch + exposure + first primary barrier are closed the signal will be transmitted to the generator for activating X-ray. During intended use only with this footswitch X-ray should be activated.