BEUDAMED
    FDA Recall Open, Classified

    ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

    Recall: Z-1073-2024 · Initiated December 15, 2023

    Recall

    Recall Number
    Z-1073-2024
    Event Number
    93773
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    JAA
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 15, 2023
    Posted
    February 9, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

    Reason

    Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

    Action

    ***UPDATE*** 19 ProxiDiagnost N90 Systems (18 US & 1 OUS) added to scope as these systems were produced prior to implementation of the solution in forward production. The newly identified consignees notified on 20 Nov 2024*** Philips issued URGENT Medical Device Correction ProxiDiagnost N90 1.1 and ProxiDiagnost Upgrade on 12/15/2024. Letter states reason for recall, health risk and action to take: For Issues 1 and 2: " To avoid previous patient data from being represented as current patient data, ensure all images have been exported from the previous RAD exam before starting a new examination. " Correct images will be square shape and wrong images can be recognized by a different patient anatomy and rectangular shape. If you identify a wrong image, flag the incorrect images and only export not flagged images for the current examination to PACS (See figure. Refer to Appendix A for specific details regarding the other issue descriptions and advice on actions to be taken. " Customers can continue using affected systems in accordance with the intended use. " Circulate this notice to all users of this device so that they are aware of the issue. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction Notice, understanding of the issue, and required actions to be taken. A Field Service Engineer (FSE) will contact you to schedule a time to visit your site and install the software upgrade to resolve the issues (Reference FCO70600110). Philips plans to start implementing the solution in Q2 2024. The software upgrade will also include software enhancements to improve clinical experience. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).

    Distribution

    Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand

    Quantity

    20 units: 16 units US; 4 units OUS