MAUDE manufacturer profile

GYRUS ACMI, INC. · FEO

MAUDE profile for Lithotriptor, Ultrasonic

Key facts

Manufacturer GYRUS ACMI, INC.
Manufacturer group GYRUS ACMI, INC.
Product code FEO
Product code name Lithotriptor, Ultrasonic

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Break, No Patient Involvement, Output Problem, Defective Device, Communication or Transmission Problem, No Consequences Or Impact To Patient, Connection Problem 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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