MAUDE manufacturer profile

MERGE HEALTHCARE · LLZ

MAUDE profile for System, Image Processing, Radiological

Key facts

Manufacturer MERGE HEALTHCARE
Manufacturer group MERGE HEALTHCARE
Product code LLZ
Product code name System, Image Processing, Radiological

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Computer Software Problem, Loss of Data, Data Problem, No Clinical Signs, Symptoms or Conditions, Patient Data Problem, Device Operates Differently Than Expected, Device Issue 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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