Hans Pausch Rontgengeratebau Gmbh: Medical Device Recall in 2017 - (Recall #: Z-2152-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 14, 2017

Date Posted: June 7, 2017

Recall Number: Z-2152-2017

Event ID: 76808

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.

Status: Terminated

Product Quantity: 10 systems

Code Information:

model numbers: 01169033 and 01169034 with the serial numbers 0103-0112

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

FDA Mandated