U.S. FDA — Device Enforcement · Germany · 2017-03-14 · Class II
As described by U.S. FDA — Device Enforcement: 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 treatmen
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
FDA Mandated
Distribution
Nationwide Distribution
Reported risk: 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.
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