MAUDE manufacturer profile
GE OEC MEDICAL SYSTEMS, INC · OWB
MAUDE profile for Interventional Fluoroscopic X-Ray System
Key facts
| Manufacturer | GE OEC MEDICAL SYSTEMS, INC |
|---|---|
| Manufacturer group | GE OEC MEDICAL SYSTEMS, INC |
| Product code | OWB |
| Product code name | Interventional Fluoroscopic X-Ray System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Information, Failure to Power Up, Device Stops Intermittently, Device Inoperable, Loss of Data, No Clinical Signs, Symptoms or Conditions, Device Displays Incorrect Message Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1