Drug recall
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA recall event 68569 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 68569 |
|---|---|
| Recall numbers | Z-2085-2014 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may… |
| Initiation date | Jun 13, 2014 |
| Report date | Jul 30, 2014 |
| Termination date | Sep 7, 2016 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: