Drug recall
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope…
FDA recall event 78441 · Class II · Fukuda Denshi Co., Ltd.
Key facts
| Event ID | 78441 |
|---|---|
| Recall numbers | Z-0203-2018 |
| Recalling firm | Fukuda Denshi Co., Ltd. |
| Product type | Devices |
| Products | Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad… |
| Initiation date | Oct 16, 2017 |
| Report date | Dec 13, 2017 |
| City | Tokyo |
| Country | Japan |
| FEI number | 3002807019 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: