CARESCAPE ONE Monitor (GE) – battery performance (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 being aware that the monitor may still shut down during patient transport. Users are advised to be prepared to provide alternate methods of assessing the clinical status of the patient, bring a mains power cord during patient transport, and bring a spare battery. GE HealthCare will correct all affected products at no cost to the customer. A GE HealthCare representative will contact each customer to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.