BEUDAMED
    FDA Recall Terminated

    MAC VU360, Model Number 2030360-001, Electrocardiograph

    Recall: Z-2060-2019 · Initiated June 28, 2019

    Recall

    Recall Number
    Z-2060-2019
    Event Number
    83270
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 28, 2019
    Terminated
    April 13, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    MAC VU360, Model Number 2030360-001, Electrocardiograph

    Reason

    Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.

    Action

    The firm issued an Urgent Medical Device Correction letter on 06/28/2019 to tis consignees by mail. This letter informed the customer of the issues and provides instructions for continued use of the system. GE Healthcare will correct the system by upgrading the software.

    Distribution

    Worldwide

    Quantity

    369 units