Device recall
Z-0202-2018: CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors…
FDA device recall · Class II · GE Medical Systems Information Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0202-2018 |
|---|---|
| Recall event | 77818 |
| Product | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport… |
| Product code | MHX |
| Recalling firm | GE Medical Systems Information Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2021 |
| 510(k) numbers | K071073 |
| 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