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GE Healthcare Finland Oy recalls CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a
Recalled November 19, 2025 · FDA recall Z-0454-2026 · 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
5935
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 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
Manufacturer(s)
GE Healthcare Finland Oy
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →