Recall Z-0454-2026— GE Healthcare Finland Oy

Name: FDA recall Z-0454-2026
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: K213234. 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. 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

K213234 — CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201Ge Medical Systems Information Technologies, Inc.·cleared 2022-04-12

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 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

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.