MAUDE manufacturer profile

GE MEDICAL SYSTEMS, LLC · JAA

MAUDE profile for System, X-Ray, Fluoroscopic, Image-Intensified

Key facts

Manufacturer GE MEDICAL SYSTEMS, LLC
Manufacturer group GE MEDICAL SYSTEMS, LLC
Product code JAA
Product code name System, X-Ray, Fluoroscopic, Image-Intensified

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
  • No Known Impact Or Consequence To Patient, Use of Device Problem, Detachment of Device or Device Component, Fall, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Detachment Of Device Component, Device Fell 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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