Device recall
Z-0661-2016: Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi…
FDA device recall · Class II · Fukuda Denshi USA, Inc.
Key facts
| Recall number (Z-number) | Z-0661-2016 |
|---|---|
| Recall event | 72953 |
| 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. |
| Product code | MHX |
| Recalling firm | Fukuda Denshi USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2016 |
| 510(k) numbers | K134046 |
| FEI number | 3000215024 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database