Z-2152-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- March 14, 2017
- Termination Date
- June 14, 2019
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 10 systems
Product 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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
model numbers: 01169033 and 01169034 with the serial numbers 0103-0112