GE Healthcare Finland Oy recalls Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a sp…

Recall date

September 26, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0453-2026

FDA classification

Class II

Brand / firm

GE Healthcare Finland Oy

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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