Recall Z-0457-2026— GE Healthcare Finland Oy
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare Finland Oy, initiated 2025-09-26. FDA's recall record names no specific 510(k) clearance for this event. Product: BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S. 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
Product description
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
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.