BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    Recall: Z-2284-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2284-2026
    Event ID
    98977
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    December 7, 2023
    Classification Date
    June 1, 2026
    Address
    Veenpluis 6, Best, N/A, Netherlands

    Description

    Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    Reason

    During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

    Code Info

    UDI (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838085275(21)131, (01)00884838099203(21)54, (01)00884838085275(21)84, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838085275(21)132, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)108, (01)00884838085275(21)108.

    Distribution

    US Nationwide distribution.

    Quantity

    16 units