Device recall
Z-0203-2018: Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of…
FDA device recall · Class II · Fukuda Denshi Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0203-2018 |
|---|---|
| Recall event | 78441 |
| Product | 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 one or more of the following parameters on an individual patient may be required. ECG (waveform… |
| Product code | MHX |
| Recalling firm | Fukuda Denshi Co., Ltd. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K134046 |
| FEI number | 3002807019 |
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