FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2152-2017
- Recalling firm
- Hans Pausch Rontgengeratebau Gmbh
- 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.
- Status
- Terminated
- Initiated
- 2017-03-14
- Posted
- not on file
- Terminated
- 2019-06-14
- 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 purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will send a list of the product locations and associated telephone number to the FDA district office. 3. You will implement this CAP by July 1, 2017. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). All actions to install this retrofit kit 01164901 have been executed until Mar 13,2017. The additional retrofit kit 01164901 was extended to additional batches of the same Uroview FD device.
- Quantity
- 10 systems
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
- 510(k) numbers
- ["K161019"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 3002807145
- Firm city
- Erlangen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28