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GE Healthcare Finland Oy recalls

The FDA has posted 5 enforcement recalls from GE Healthcare Finland Oy since 2025, none of them Class I (most serious). Most recent report: Nov 19, 2025.

Class II: 5
Class IIOngoingZ-0455-2026

GE Healthcare Finland Oy recalls B105P

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.…

  • Patient(With Arrhythmia Detection Or Alarms) Physiological Monitor
  • Component change control
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0454-2026

GE Healthcare Finland Oy recalls CARESCAPE ONE

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.…

  • Patient(With Arrhythmia Detection Or Alarms) Physiological Monitor
  • Component change control
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0456-2026

GE Healthcare Finland Oy recalls Portrait VSM Model nos. 6660000-666 Monitor

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.…

  • Patient(With Arrhythmia Detection Or Alarms) Physiological Monitor
  • Component change control
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0453-2026

GE Healthcare Finland Oy recalls Carescape B450

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.…

  • Patient(With Arrhythmia Detection Or Alarms) Physiological Monitor
  • Component change control
GE Healthcare Finland…Nov 19, 2025

Firm name as filed with the FDA: “GE Healthcare Finland Oy”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.