Fukuda Denshi USA, Inc. recalls Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Mon…
- Recall date
- December 21, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0661-2016
- FDA classification
- Class II
- Brand / firm
- Fukuda Denshi USA, Inc.
- Sold / distributed
- Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
Why it was recalled
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).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever Fukuda Denshi USA, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Fukuda Denshi USA, Inc.