BEUDAMED
    FDA Recall Terminated

    Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies

    Recall: Z-1843-2020 · Initiated August 30, 2019

    Recall

    Recall Number
    Z-1843-2020
    Event Number
    84902
    Firm
    Philips Ultrasound Inc
    FEI Number
    3019216
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 30, 2019
    Terminated
    November 27, 2024
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies

    Reason

    The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury

    Action

    If you have an EPIQ, Affiniti or iE33 system, verify that all your S7-3t and S8-3t TEE transducers are programmed properly by connecting them to the system, checking the transducer temperature (TEE T) on the display, and following the instructions provided on this letter. If you determine that your transducer is not properly programmed, discontinue using the transducer immediately and contact your local Philips representative to schedule an appointment with a field service engineer. If you have an HD11 or CX50 system discontinue using the S7-3t and S8-3t transducer immediately and contact your local Philips representative for support. Please complete the included reply form on the last page and return to Philips as soon as possible via email to [email protected], or fax to 1-833-512-7756.

    Distribution

    Worldwide distribution - US Nationwide distribution.