BEUDAMED
    FDA Recall Terminated

    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    Recall: Z-2096-2021 · Initiated May 17, 2021

    Recall

    Recall Number
    Z-2096-2021
    Event Number
    88166
    Firm
    Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of)
    FEI Number
    3003591740
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 17, 2021
    Terminated
    November 4, 2022

    Description

    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    Reason

    In some cases the equipment fails to power up and/or key or button unresponsive or not working.

    Action

    The firm sent a "URGENT : Field Safety Notice(Correction)" email dated May 17, 2021 to its consignee. The email describes the product, problem and actions to be taken. The following actions were to be implemented: Implementation of action plan (1) Inventory stock a importer's hand: Mediana service engineer will update before ship to end users. (2) The products at end user's hand: Provide the modified new Software via USB memory stick and instruction for upgrading the S/W 3. Required actions for the user - INSPECT the inventory for the affected Model number, serial number(s), and date of manufacture. - IF USER HAVE affected devices Contact Customer Technical Services or Sales Representative for correction. - RETURN the enclosed acknowledgement form to Mediana USA service center. - UPGRADE THE S/W with the received s/w according to the instruction. - IF ANY Problem occurred during the upgrade Contact Customer Technical Services or Sales Representative. If you have any questions, contact QMS Representative at +82 70 7092 9945; email: [email protected]. or Sales Representative at +82 70 7092 9525; email: [email protected]. or Technical Services at 425-406-2262; email: [email protected].

    Distribution

    US Distribution to: Wisconsin only

    Quantity

    618