Device recall
Z-0487-2018: GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The…
FDA device recall · Class II · GE Medical Systems Information Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0487-2018 |
|---|---|
| Recall event | 78918 |
| Product | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and… |
| Product code | DQK |
| Recalling firm | GE Medical Systems Information Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 7, 2021 |
| 510(k) numbers | K162012 |
| FEI number | 2124823 |
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