BEUDAMED
    FDA Enforcement Class III Ongoing

    L12-5 38mm Transducer Probe

    Recall: Z-2375-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2375-2025
    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

    L12-5 38mm Transducer Probe

    Reason

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

    Code Info

    Model No. 989605428532; UDI: (01)00884838073623(21)B305XD, (01)00884838073623(21)F05R7X, (01)00884838073623(21)B1Y35V, (01)00884838073623(21)B305ZX, (01)00884838073623(21)F05K8W, (01)00884838073623(21)B3GWRJ, (01)00884838073623(21)B1Y306, (01)00884838073623(21)B1Y3CG, (01)00884838073623(21)B1Q699, (01)00884838073623(21)B1Y3C4, (01)00884838073623(21)B1RXWK, (01)00884838073623(21)B305X5, (01)00884838073623(21)B305ZK, (01)00884838073623(21)B3NFD5, (01)00884838073623(21)F034C6; Serial No. B305XD, F05R7X, B1Y35V, B305ZX, F05K8W, B3GWRJ, B1Y306, B1Y3CG, B1Q699, B1Y3C4, B1RXWK, B305X5, B305ZK, B3NFD5, F034C6.

    Distribution

    US Nationwide distribution.

    Quantity

    171,322 units