The Recall Desk
HighFDA (Devices)·Z-2152-2017·Announced 2017-06-07

Hans Pausch Uroview FD Fluoroscopic X-ray System Recalled for Footswitch Safety Issue

Hans Pausch is recalling 10 Uroview FD fluoroscopic X-ray systems because the footswitch used to activate radiation is part of the safety circuit.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect in a safety circuit that controls radiation exposure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Hans Pausch Rontgengeratebau Gmbh is recalling 10 Pausch Uroview FD fluoroscopic X-ray systems. These systems are primarily used for urological applications, including functional X-ray diagnostics, endourology, and minimal invasive urology or surgery. The affected units include model numbers 01169033 and 01169034 with serial numbers 0103-0112.

The recall is due to a safety concern regarding the footswitch connected to the urology table. During patient interventions, this footswitch is used to activate radiation and is actively involved in the safety circuit of the table. The system is designed so that the X-ray signal is only transmitted to the generator when the footswitch, exposure, and first primary barrier are all closed. The source text notes that during intended use, X-ray should only be activated with this specific footswitch.

The recall is distributed nationwide. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. Users of these systems should contact the manufacturer for further instructions on how to address the safety circuit issue.

The recalled product

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
Manufacturer
Hans Pausch Rontgengeratebau Gmbh
Category
Medical Device — Fluoroscopic X-ray System
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · radiation exposure

See all →