BEUDAMED
    FDA Enforcement Class II Ongoing

    MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

    Recall: Z-2306-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2306-2026
    Event ID
    98917
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems China Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    June 10, 2026
    Initiation Date
    April 21, 2026
    Classification Date
    June 3, 2026
    Address
    No. 19 Changjiang Road, Development Zone National Hi-Tech Xin District, Wuxi, N/A, China

    Description

    MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

    Reason

    Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.

    Code Info

    Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124

    Distribution

    Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.

    Quantity

    16