MAUDE manufacturer profile

CARESTREAM HEALTH INC. · KPR

MAUDE profile for System, X-Ray, Stationary

Key facts

Manufacturer CARESTREAM HEALTH INC.
Manufacturer group CARESTREAM HEALTH INC.
Product code KPR
Product code name System, X-Ray, Stationary

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Mechanical Problem, No Patient Involvement, Injury, Radiation Overexposure, Unintended Movement, Fire, Radiation Output 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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