Recall of HIVISION Preirus, Avius ultrasound systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hitachi Medical Systems America 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    Software anomaly. the doppler trace measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. the recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead.
  • Action
    The firm, Hitachi, sent a "DEVICE CORRECTION NOTICE" letter dated April 15, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were inform of the nature of the software error in the Doppler Trace Measurement feature; the circumstances under which this error can occur; and the safety issue involved should incorrect values generated lead to a false diagnosis of stenosis in a patient. The letter provides the customer with a workaround solution in order to avoid this issue. The customer were also instructed to call the HMSA Applications Helpline at 877-871-2777 to reprogram their system to temporarily eliminate the noted safted issue and to immediately have all selections unchecked on the Doppler trace measurement result store setting set up screen. The notification letter also states that Hitachi Medical Systems America (HMSA) will be having their service personnel schedule a visit at each customer location and install a software upgrade on each affected system unit in order to directly address, and permanently resolve this issue. If you need any further information regarding this notice, please contact the Manager of Regulatory Affairs at 800-800-3106 x3720 or email to:


  • Model / Serial
    All codes manufactured from 11/2/2009 to 3/4/2011, are subject to recall. Preirus (KE10584001-KE17585003)/Avius (KE11088001-KE11476102)
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide distribution: USA including states of: CA, MD, KY, FL, MN, NJ, IA, OH, TX, IL, and IA.
  • Product Description
    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). || The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.
  • Manufacturer


  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Manufacturer Parent Company (2017)
  • Source