BEUDAMED
    FDA Recall Terminated

    Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

    Recall: Z-0612-2019 · Initiated November 7, 2018

    Recall

    Recall Number
    Z-0612-2019
    Event Number
    81706
    Firm
    Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany
    FEI Number
    3003768251
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    November 7, 2018
    Terminated
    September 2, 2020

    Description

    Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

    Reason

    kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

    Action

    On November 7, 2018, Philips Medical Systems distributed an URGENT MEDICAL DEVICE RECALL" notices dated 10/16/2018 to customers. The following are Actions to Be Taken by the Customer: **If the kV/mA lockin not functioning as specified**: The operator can recognize the issue by observing the increasing mA value. In general the system can be used according to the Instruction for Use without restrictions. **If the Stitching with SkyPlate aborts after first image**: There are no actions to be taken by the user in these situations. The customer is notified at the end of the stitching run that the run failed. Customers can continue to use the device in accordance with this notice and the IfU. Philips will provide an upgrade of all CombiDiagnost R90 systems in the field to Rel.1.0.3 (Eleva package incl. improved clinical EPX database). A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70900042. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    146