MAUDE manufacturer profile

GE MEDICAL SYSTEMS, LLC · KPS

MAUDE profile for System, Tomography, Computed, Emission

Key facts

Manufacturer GE MEDICAL SYSTEMS, LLC
Manufacturer group GE MEDICAL SYSTEMS, LLC
Product code KPS
Product code name System, Tomography, Computed, Emission

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Mechanical Problem, Loss of Data, Therapeutic or Diagnostic Output Failure, Output Problem, Improper or Incorrect Procedure or Method, Application Program Version or Upgrade Problem, Device Displays Incorrect Message, Problem with Software 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

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