MAUDE manufacturer profile

AGFA N.V. · IZL

MAUDE profile for System, X-Ray, Mobile

Key facts

Manufacturer AGFA N.V.
Manufacturer group AGFA N.V.
Product code IZL
Product code name System, X-Ray, Mobile

At a glance

  • 10–99 MAUDE reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Unintended System Motion, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Unintended Movement, Detachment of Device or Device Component, No Consequences Or Impact To Patient, Insufficient Information, Device Displays Incorrect Message 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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