FDAMarch 14, 2017device

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 treatme...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

hans pausch rontgengeratebauhanshans pausch

UPCs

04260491620040

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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