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Hans Pausch Rontgengeratebau Gmbh recalls Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (funct
Recalled June 7, 2017 · FDA recall Z-2152-2017 · Hans Pausch Rontgengeratebau
Hazard
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. · FDA Class II
Units
10 systems
Sold at
Nationwide Distribution
Description
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.
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.
Manufacturer(s)
Hans Pausch Rontgengeratebau Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →