Class II — Fukuda Denshi USA, Inc.
| Recalling firm | Fukuda Denshi Co., Ltd. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 95 units distributed in the US |
| Distribution | Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI. |
| Initiated | 2015-12-21 |
| Classified | 2016-01-15 |
| Terminated | 2016-08-19 |
| Recall number | Z-0661-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Fukuda Denshi USA, Inc. (Z-0661-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72953/
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