Device recall
Z-0399-2016: The eCareManager system. Software intended for use in data collection, storage…
FDA device recall · Class II · Visicu, Inc.
Key facts
| Recall number (Z-number) | Z-0399-2016 |
|---|---|
| Recall event | 70931 |
| Product | The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to… |
| Product code | MSX |
| Recalling firm | Visicu, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2016 |
| 510(k) numbers | K001972, K012171 |
| FEI number | 3003063823 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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