FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 7 de junio de 2017 · Inicio del retiro: 14 de marzo de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
FDA Mandated · Letter
Detalles del retiro
- Fabricante
- Hans Pausch Rontgengeratebau Gmbh
- Distribuidor
- Nationwide Distribution
- Lote
- model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Germany