Reported Jun 7, 2017 · Terminated
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications…
Hans Pausch Rontgengeratebau GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hans Pausch Rontgengeratebau Gmbh · Graf Zeppelin Strasse 1 · Erlangen · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- model numbers01169033 and 01169034 with the serial numbers 0103-0112
- Amount recalled
- 10 systems
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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