MAUDE manufacturer profile
GE MEDICAL SYSTEMS SCS · IZI
MAUDE profile for System, X-Ray, Angiographic
Key facts
| Manufacturer | GE MEDICAL SYSTEMS SCS |
|---|---|
| Manufacturer group | GE MEDICAL SYSTEMS SCS |
| Product code | IZI |
| Product code name | System, X-Ray, Angiographic |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Device Operates Differently Than Expected, No Clinical Signs, Symptoms or Conditions, Appropriate Term / Code Not Available, Death, No Information, Unintended Movement, Loss of Power 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