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.
Enforcement
- Recall Number
- Z-2152-2017
- Event ID
- 76808
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hans Pausch Rontgengeratebau Gmbh
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- June 7, 2017
- Initiation Date
- March 14, 2017
- Classification Date
- May 30, 2017
- Termination Date
- June 14, 2019
- Address
- Graf Zeppelin Strasse 1, Erlangen, N/A, Germany
Description
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.
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.
model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
Nationwide Distribution
10 systems