Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0457-2026 — 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

U.S. FDA — Device Enforcement · Finland · 2025-09-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0457-2026
Date of alert
2025-09-26
Country / jurisdiction
Finland
Risk level
Class II
Risk type
recall
Brand
GE Healthcare Finland Oy
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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