Device recall
Z-1474-2012: Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8…
FDA device recall · Class II · Visicu, Inc.
Key facts
| Recall number (Z-number) | Z-1474-2012 |
|---|---|
| Recall event | 61328 |
| Product | Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected… |
| Product code | MSX |
| Recalling firm | Visicu, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2012 |
| 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