FDA-Device2016-01-27Class II
Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.
Fukuda Denshi USA, Inc.
Hazard
A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).
Sold states
Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
Affected count
95 units distributed in the US
Manufactured in
17725 NE 65th St Ste C, N/A, Redmond, WA, United States
Products
Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0661-2016Don't want to check this manually?
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