Recall Z-2152-2017 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Hans Pausch Rontgengeratebau Gmbh
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.
| Date | Mar 14, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Pausch Medical will bring defect into compliance : The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 10 units will consist of the following: 1. You will contact customers and initiate the hardware upgrade to correct the noncompliance. 2. You will install the hardware upgrade and perform testing to ensure this update was effective. 3. Your customer notification will include a statement that you will without charge, bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchase |
| Quantity | 10 systems |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161019 | Uroview FD Pausch Medical GmbH, Aug 17, 2016 |