Events

Recall of Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System

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
    35107
  • Event Risk Class
    Class 2
  • Event Number
    Z-1115-06
  • Event Initiated Date
    2006-04-25
  • Event Date Posted
    2006-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45329
  • 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
    MRI - Product Code LNH
  • Reason
    Improper assembly-the airis/airis ii mri system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.
  • Action
    The recalling firm plans to inspect the transformer connections for damaged wiring and check the connections for tightness and tighten as necessary. The inspections and possible corrections began on 4/25/2006 and are in the process of being conducted by the firm''s Field Service Engineers. The firm anticipates trhat these actions will be completed by 6/25/2006.

Device

Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System
  • Model / Serial
    Serial Numbers: C322- to C546; and C746 to C772
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The devices were distributed to consignees located throughout the United States.
  • Product Description
    Hitachi AIRIS II MRI System
  • 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