BEUDAMED
    FDA Recall Open, Classified

    CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

    Recall: Z-2279-2026 · Initiated April 24, 2026

    Recall

    Recall Number
    Z-2279-2026
    Event Number
    98932
    Firm
    GE Medical Systems Information Technologies Inc
    FEI Number
    3012359877
    Product Code
    DQK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 24, 2026
    Posted
    June 1, 2026
    Address
    9900 W Innovation Dr, Milwaukee, WI, 53226-4856

    Description

    CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

    Reason

    Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.

    Action

    Firm notified consignees starting on April 24, 2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION." Pending corrections from GE Healthcare, customers were instructed to perform a visual inspection of the printer assembly to verify proper positioning of the ESD brush. Customers may continue to use the device if the brush is properly positioned and aligned. However, if the brush appears misaligned or displaced, stop using the device and contact a GE HealthCare Service representative.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Bangladesh, Cambodia, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    1835