Device recall
Z-0918-2025: Portrait Core Services, a set of software services that enable the communication…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0918-2025 |
|---|---|
| Recall event | 96027 |
| Product | Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB |
| Product code | MWI |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K234130 |
| FEI number | 2126677 |
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