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Fukuda Denshi USA, Inc. recalls Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient M
Recalled January 27, 2016 · FDA recall Z-0661-2016 · Fukuda Denshi USA
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). · FDA Class II
Units
95 units distributed in the US
Sold at
Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
Description
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).
Product
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.
Manufacturer(s)
Fukuda Denshi USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →