Events

Recall of Device Recall Hitachi AIRIS II Magnetic Resonance Imaging Device

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
    32211
  • Event Risk Class
    Class 2
  • Event Number
    Z-0889-05
  • Event Initiated Date
    2005-06-30
  • Event Date Posted
    2005-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39393
  • 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, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Reason
    Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
  • Action
    The recalling firm is sending recall letters to all consignees.

Device

Device Recall Hitachi AIRIS II Magnetic Resonance Imaging Device
  • Model / Serial
    C002 thru C795, C907, and C910.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed throughout the United States and to one consignee located in both Wales and London.
  • Product Description
    Hitachi AIRIS II Magnetic Resonance Imaging Device
  • 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 44087-2371
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    USFDA