MAUDE manufacturer profile

SEDECAL · IZL

MAUDE profile for System, X-Ray, Mobile

Key facts

Manufacturer SEDECAL
Manufacturer group SEDECAL SA
Product code IZL
Product code name System, X-Ray, Mobile

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Insufficient Information, Computer Operating System Problem, Unintended System Motion, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Unintended Movement, Mechanical Problem, Loose or Intermittent Connection 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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