BEUDAMED
    FDA Enforcement Class III Ongoing

    BP10-5ec Transducer Probe

    Recall: Z-2349-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2349-2025
    Event ID
    97217
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Ultrasound, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2025
    Initiation Date
    July 3, 2025
    Classification Date
    August 22, 2025
    Address
    1 Echo Dr, Reedsville, PA, 17084-8603, United States

    Description

    BP10-5ec Transducer Probe

    Reason

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

    Code Info

    Model No. 989605395642; UDI: (01)00884838061552(21)B29VPV, (01)00884838061552(21)B29VQ6, (01)00884838061552(21)B2CYJ4, (01)00884838061552(21)F06M63, (01)00884838061552(21)F06QYR, (01)00884838061552(21)B2CY7P, (01)00884838061552(21)F058R4, (01)00884838061552(21)B2CY8T, (01)00884838061552(21)F05YF6, (01)00884838061552(21)F0628C, (01)00884838061552(21)B29VPW, (01)00884838061552(21)F064N9, (01)00884838061552(21)F078HF, (01)00884838061552(21)F05Y6Y, (01)00884838061552(21)B2CYJJ, (01)00884838061552(21)B2CYD7; Serial No. B29VPV, B29VQ6, B2CYJ4, F06M63, F06QYR, B2CY7P, F058R4, B2CY8T, F05YF6, F0628C, B29VPW, F064N9, F078HF, F05Y6Y, B2CYJJ, B2CYD7.

    Distribution

    US Nationwide distribution.

    Quantity

    171,322 units