MAUDE manufacturer profile
GE OEC MEDICAL SYSTEMS GMBH · JAA
MAUDE profile for System, X-Ray, Fluoroscopic, Image-Intensified
Key facts
| Manufacturer | GE OEC MEDICAL SYSTEMS GMBH |
|---|---|
| Manufacturer group | GE OEC MEDICAL SYSTEMS GMBH |
| Product code | JAA |
| Product code name | System, X-Ray, Fluoroscopic, Image-Intensified |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1,000+ 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, Computer Operating System Problem, Patient Data Problem, Device Displays Incorrect Message, Device Inoperable 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