MAUDE manufacturer profile

GE MEDICAL SYSTEMS, LLC · JAK

MAUDE profile for System, X-Ray, Tomography, Computed

Key facts

Manufacturer GE MEDICAL SYSTEMS, LLC
Manufacturer group GE MEDICAL SYSTEMS, LLC
Product code JAK
Product code name System, X-Ray, Tomography, Computed

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Sharp Edges, Laceration(s), Insufficient Information, Improper or Incorrect Procedure or Method, Adverse Event Without Identified Device or Use Problem, Mechanical Problem, Head Injury 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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