Drug recall
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and…
FDA recall event 81058 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 81058 |
|---|---|
| Recall numbers | Z-0519-2019, Z-0520-2019, Z-0521-2019, Z-0522-2019, Z-0523-2019, Z-0524-2019 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients., Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients., Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients., Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients., Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. and 1 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. |
| Initiation date | Aug 31, 2018 |
| Report date | Dec 5, 2018 |
| 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: