FDA recall Z-0457-2026

GE Healthcare Finland Oy · Class II · device

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 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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-09-26
Report date: 2025-11-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Helsinki, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0457-2026