BEUDAMED
    2 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters Country: Finland × Status: Ongoing × Clear all

    CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·November 19, 2025

    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

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·November 19, 2025