Recall of Device Recall Aplio 500/400/300 Diagnostic Ultrasound System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • Reason
    Toshiba medical systems has received reports of startup issues with the toshiba tus-500 and tus-300 ultrasound systems. the startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. it has been determined that this may potentially cause damage to the system.
  • Action
    Toshiba sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 11, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (800) 421-1968 for questions regarding this letter.


  • Model / Serial
    Item numbers: TUS-A300/Wl and TUS-A500/Wl
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution.
  • Product Description
    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). || Device Listing Number: Dl53118. || Diagnostic Ultrasound system.
  • Manufacturer


  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Manufacturer Parent Company (2017)
  • Source