Events

Recall of Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems 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
    62853
  • Event Risk Class
    Class 2
  • Event Number
    Z-2278-2012
  • Event Initiated Date
    2008-05-13
  • Event Date Posted
    2012-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111875
  • 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
    The status display in the sequence queue window may not change from "current" to "done".
  • Action
    A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968.

Device

Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504
  • Model / Serial
    Models MRT-1503 and MRT-1504  " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. || Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA