FDA-Device2025-11-19Class IIPROCESSING DEFECT
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
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
2857
Manufactured in
Kuortaneenkatu 2, Helsinki, Finland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0457-2026Want us to check the next one for you?
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