Z-2152-2017Class II

Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological...

Name: Z-2152-2017 Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological...
Creator: Hans Pausch Rontgengeratebau Gmbh
Published: 2017-03-14
License: https://open.fda.gov/license/

PAUSCH Medical GmbH / initiated 2017-03-14 / Terminated / root cause: design

FDA source

Hans Pausch Rontgengeratebau Gmbh began a recall of Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and... on 2017-03-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2152-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-14
Posted: 2017-05-30
Terminated: 2019-06-14
Recalling firm: PAUSCH Medical 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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: design
FDA 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 in commerce: 10 systems
Distribution: Nationwide Distribution
Product codes and lots: model numbers: 01169033 and 01169034 with the serial numbers 0103-0112

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2152-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2017	Class II	Terminated	FDA Mandated	2017-06-07	2017-05-30

Product code JAA

K161019Class IIUroview FDPausch Medical GmbH / cleared 2016-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)