FDADecember 21, 2015device

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 recall recorded by the U.S. Food & Drug Administration.

The 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).

What to do

FDA enforcement status: Terminated

Brands named

fukuda denshifukuda

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear