MAUDE manufacturer profile
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · KPS
MAUDE profile for System, Tomography, Computed, Emission
Key facts
| Manufacturer | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
|---|---|
| Manufacturer group | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Product code | KPS |
| Product code name | System, Tomography, Computed, Emission |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Mechanical Problem, No Clinical Signs, Symptoms or Conditions, Improper or Incorrect Procedure or Method, Bone Fracture(s), No Patient Involvement, Laceration(s), Use of Device Problem, Misassembled During Installation 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