BEUDAMED
    FDA Recall Open, Classified

    Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001

    Recall: Z-0453-2026 · Initiated September 26, 2025

    Recall

    Recall Number
    Z-0453-2026
    Event Number
    97786
    Firm
    GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland
    FEI Number
    3002806783
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    September 26, 2025
    Posted
    November 7, 2025

    Description

    Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001

    Reason

    Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

    Action

    On September 26, 2025, the recalling firm began notifying affected customers. A second letter was issued on October 3, 2025 which addressed a correction to Affected Product Details information. The customer letter advised users to use a monitor with a battery that is not within the affected battery population. However, pending correction by GE HealthCare, users may continue to use a monitor with affected batteries by following instructions included in the letter. These instructions include having mains power connected whenever possible, confirming appropriate battery status prior to use, and being aware that the monitor may still shut down during patient transport. Users are advised to be prepared to provide alternate methods of assessing the clinical status of the patient, bring a mains power cord during patient transport, and bring a spare battery. GE HealthCare will correct all affected products at no cost to the customer. A GE HealthCare representative will contact each customer to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    3271