Events

Recall of Device Recall Hi Visionultrasound diagnostic scanners

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
    Recall
  • Event ID
    52434
  • Event Risk Class
    Class 2
  • Event Number
    Z-2055-2009
  • Event Initiated Date
    2008-05-12
  • Event Date Posted
    2009-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82982
  • 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
    Diagnostic ultrasonic transducer - Product Code ITX
  • Reason
    The firm's parent company discovered a dicom uid (universal identifier) code mix-up which can occur due to a software error. this error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.
  • Action
    HMSA issued a 'DEVICE CORRECTION' notification to their customers on 5/12/2008. The notification describes the potential data transmission problem (potential to archive studies done on different patients into the same patient folder) and the conditions under which this problem can occur. The notification cautions the user/customer to verify all images stored on the PACS (Picture Archiving and Communications System) in order to ensure that they do not contain images from a different patient. The DEVICE CORRECTION letter also states that the firm will be installing updated software on all affected systems beginning in June, 2008, in order to address this issue. It also states that a Hitachi Service Rep. will be contacting each customer and making arrangements to set up a convenient time to come out and perform a software upgrade. Lastly, the letter provides a toll-free telephone # to the firm's 'Customer Service Center: 1-800-800-4925, which the customer can use to obtain additional information, if desired.

Device

Device Recall Hi Visionultrasound diagnostic scanners
  • Model / Serial
    The following Serial Numbers of this device were subject to recall/software correction: 17084306, 17084308, 19921303, 17268307, 17268309, and 18190406.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.
  • Product Description
    EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, || DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

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