MAUDE manufacturer profile

SHIRAKAWA OLYMPUS CO., LTD. · IYN

MAUDE profile for System, Imaging, Pulsed Doppler, Ultrasonic

Key facts

Manufacturer SHIRAKAWA OLYMPUS CO., LTD.
Manufacturer group SHIRAKAWA OLYMPUS CO., LTD.
Product code IYN
Product code name System, Imaging, Pulsed Doppler, Ultrasonic

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Poor Quality Image, Pneumothorax, Adverse Event Without Identified Device or Use Problem, No Display/Image, Material Separation, Communication or Transmission Problem, Mechanical Jam 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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