Recall Z-2152-2017— Hans Pausch Rontgengeratebau Gmbh

Name: FDA recall Z-2152-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-14

Class II · Terminated

Class II FDA medical device recall by Hans Pausch Rontgengeratebau Gmbh, initiated 2017-03-14, terminated 2019-06-14. It names one FDA 510(k) clearance: K161019. 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.. Reason: 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..

Recalling firm: Hans Pausch Rontgengeratebau Gmbh
Classification: Class II
Status: Terminated
Initiated: 2017-03-14
Terminated: 2019-06-14
Firm location: Erlangen, Germany

510(k) clearances named in this recall

1 on FDA's record

K161019 — Uroview FDPausch Medical GmbH·cleared 2016-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.