Events

Recall of Device Recall Pausch Medical Uroview FD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hans Pausch Rontgengeratebau Gmbh.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76808
  • Event Risk Class
    Class 2
  • Event Number
    Z-2152-2017
  • Event Initiated Date
    2017-03-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154240
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 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.
  • 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.

Device

Device Recall Pausch Medical Uroview FD
  • Model / Serial
    model numbers: 01169033 and 01169034 with the serial numbers 0103-0112
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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.
  • Manufacturer
    Hans Pausch Rontgengeratebau Gmbh

Manufacturer

Hans Pausch Rontgengeratebau Gmbh
  • Manufacturer Address
    Hans Pausch Rontgengeratebau Gmbh, Graf Zeppelin Strasse 1, Erlangen Germany
  • Source
    USFDA