Device recall
Z-2154-2008: Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part…
FDA device recall · Class II · Datex Ohmeda, Inc. dba GE Healthcare
Key facts
| Recall number (Z-number) | Z-2154-2008 |
|---|---|
| Recall event | 48467 |
| Product | Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02. |
| Product code | HGM |
| Recalling firm | Datex Ohmeda, Inc. dba GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2012 |
| FEI number | 1121732 |
At a glance
- None 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