Recall Z-0454-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare Finland Oy
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
| Date | Nov 7, 2025 (initiated Sep 26, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Component change control |
| Action | On September 26, 2025, the recalling firm began notifying affected customers. A second letter was issued on October 3, 2025 which addressed a correction to Affected Product Details information. The customer letter advised users to use a monitor with a battery that is not within the affected battery population. However, pending correction by GE HealthCare, users may continue to use a monitor with affected batteries by following instructions included in the letter. These instructions include having mains power connected whenever possible, confirming appropriate battery status prior to use, and |
| Quantity | 5935 |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Ge Medical Systems Information Technologies, Inc., Apr 12, 2022 |