Events

Recall of Device Recall MRP7000 AIRIS 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
    35103
  • Event Risk Class
    Class 2
  • Event Number
    Z-1105-06
  • Event Initiated Date
    2006-03-17
  • Event Date Posted
    2006-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45324
  • 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 magnetic resonance imaging devices - Product Code LNH
  • Reason
    Software anomaly. a software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. this image error could result in a possible patient mis-diagnosis.
  • Action
    On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.

Device

Device Recall MRP7000 AIRIS magnetic resonance imaging devices
  • Model / Serial
    Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide-The devices were distributed to consignees located througout the United States.
  • Product Description
    MRP-7000, AIRIS Magnetic Resonance Imaging 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