BEUDAMED
    FDA Enforcement Class III Ongoing

    Philips 3D6-2 Ultrasound Transducer

    Recall: Z-1618-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1618-2026
    Event ID
    97643
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Ultrasound, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2026
    Initiation Date
    September 5, 2025
    Classification Date
    March 24, 2026
    Address
    1 Echo Dr, Reedsville, PA, 17084-8603, United States

    Description

    Philips 3D6-2 Ultrasound Transducer

    Reason

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

    Code Info

    Model No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F.

    Distribution

    US Nationwide distribution.

    Quantity

    17 units