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U.S. Department of Health and Human Services

Class 2 Device Recall Pausch Medical Uroview FD

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  Class 2 Device Recall Pausch Medical Uroview FD see related information
Date Initiated by Firm March 14, 2017
Create Date May 30, 2017
Recall Status1 Terminated 3 on June 14, 2019
Recall Number Z-2152-2017
Recall Event ID 76808
510(K)Number K161019  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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.
Code Information model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
Recalling Firm/
Manufacturer		 Hans Pausch Rontgengeratebau Gmbh
Graf Zeppelin Strasse 1
Erlangen Germany
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = PAUSCH MEDICAL GMBH
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