Fukuda Denshi patient monitor model DS-8100M and DS-8100N — Class II medical device recall Z-0661-2016
Terminated recall by Fukuda Denshi USA, Inc., reported 2016-01-27, distributed in CO, ID, KS, MI, MO, OR, PA, TX…. A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad
| Recall number | Z-0661-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fukuda Denshi USA, Inc., Redmond, WA, United States |
| Recall initiated | 2015-12-21 |
| Classified | 2016-01-15 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-08-19 |
| Distributed | CO, ID, KS, MI, MO, OR, PA, TX, UT, WI |
| Quantity | 95 units |
| Reason classes | device malfunction |
| Model numbers | DS-8100M, DS-8100N, DS-8100N/8100M |
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.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0661-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.