Events

Recall of AIRIS II, Altaire Magnetic Resonance Imaging Devices

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
    35100
  • Event Risk Class
    Class 2
  • Event Number
    Z-1104-06
  • Event Initiated Date
    2006-04-28
  • Event Date Posted
    2006-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45322
  • 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
    Magnetic Resonance Imaging MRI - Product Code LNH
  • Reason
    Software anomaly-a software defect can cause the slice line indicator to become mis-positioned during multi-planar reconstructions (mpr) with the potential for patient mis-diagnosis.
  • Action
    The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.

Device

AIRIS II, Altaire Magnetic Resonance Imaging Devices
  • Model / Serial
    Serial Numbers: Altaire - L217, L219, L221, L224 and L225; AIRIS II - C686-C688* [*The AIRIS units remained in Hitachi's inventory and were not distributed].
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
  • Product Description
    AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
  • 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