BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1073-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1073-2024
    Event ID
    93773
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    December 15, 2023
    Classification Date
    February 9, 2024
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    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)

    Code Info

    UDI: N/A Serial Numbers US: 4 5 6 7 8 9 11 12 13 14 17 18 61 692222229 692222254 692222263 Serial Numbers OUS: 53 56 65 692222227

    Distribution

    Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand

    Quantity

    20 units: 16 units US; 4 units OUS