Recall Z-0453-2026— GE Healthcare Finland Oy

Name: FDA recall Z-0453-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare Finland Oy, initiated 2025-09-26. It names one FDA 510(k) clearance: K213363. 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. Reason: 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..

Recalling firm: GE Healthcare Finland Oy
Classification: Class II
Status: Ongoing
Initiated: 2025-09-26
Firm location: Helsinki, Finland

510(k) clearances named in this recall

1 on FDA's record

K213363 — CARESCAPE B450, E-musbGE Healthcare Finland Oy·cleared 2022-04-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.