Pausch Uroview FD fluoroscopic X-ray system UDI number — Class II medical device recall Z-2152-2017
Terminated recall by Hans Pausch Rontgengeratebau Gmbh, reported 2017-06-07, distributed nationwide. During patient interventions with the urology table the radiation is activated with a footswitch connected to
| Recall number | Z-2152-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Hans Pausch Rontgengeratebau Gmbh, Erlangen, Germany |
| Recall initiated | 2017-03-14 |
| Classified | 2017-05-30 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2019-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 10 systems |
| UPC / GTIN / UDI-DI | 04260491620040 |
| Serial numbers | 0103-0112 |
| Model numbers | 01169033, 01169034 |
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 urological treatment, planning and diagnostic procedures, including but not limited to.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2152-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.