MAUDE manufacturer profile
GE MEDICAL SYSTEMS SCS · OWB
MAUDE profile for Interventional Fluoroscopic X-Ray System
Key facts
| Manufacturer | GE MEDICAL SYSTEMS SCS |
|---|---|
| Manufacturer group | GE MEDICAL SYSTEMS SCS |
| Product code | OWB |
| Product code name | Interventional Fluoroscopic X-Ray System |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Insufficient Information, No Known Impact Or Consequence To Patient, Improper or Incorrect Procedure or Method, Laceration(s), Death, No Patient Involvement 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