Hans Pausch Rontgengeratebau Gmbh recalls Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functi…

Recall date

March 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2152-2017

FDA classification

Class II

Brand / firm

Hans Pausch Rontgengeratebau Gmbh

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.