BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2306-2026 · Initiated April 21, 2026

    Recall

    Recall Number
    Z-2306-2026
    Event Number
    98917
    Firm
    GE Medical Systems China Co., Ltd. No. 19 Changjiang Road Development Zone National Hi-Tech Xin District Wuxi China
    FEI Number
    3003513129
    Product Code
    DXH
    Status
    Open, Classified
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    April 21, 2026
    Posted
    June 3, 2026

    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.

    Action

    Firm notified consignees beginning April 21, 2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION". Customers were given instructions on how to check their software version. If a customer's software version begins with 3.00, the customer should not use the system until a GE HealthCare representative has updated the device with the latest licensed software version.

    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