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GE Healthcare Finland Oy recalls Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spa
Recalled November 19, 2025 · FDA recall Z-0453-2026 · GE Healthcare Finland Oy
Hazard
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. · FDA Class II
Units
3271
Sold at
Worldwide - US Nationwide distribution.
Description
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.
Product
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
Manufacturer(s)
GE Healthcare Finland Oy
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →