FDAFDA · Food and drugs·Recall number Z-2152-2017
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.
Published June 7, 2017 · Recall initiated: March 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Hans Pausch Rontgengeratebau Gmbh
- Distributor
- Nationwide Distribution
- Lot
- model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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