Events

Recall of Magnetic Resonance Imaging Systems under the following names: || Visart || Excelart || Excelart P2 || Excelart P3 || Excelart SPIN || Excelart VANTAGE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Med Sys 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
    30408
  • Event Risk Class
    Class 2
  • Event Number
    Z-0270-05
  • Event Initiated Date
    2004-10-06
  • Event Date Posted
    2004-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35816
  • 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
    Software defect causes images to be rotated 180 degrees.
  • Action
    Firm sent a letter to consignees October 6, 2004 describing the observed conditions causing the flaw to manifest itself. A workaround solution is also described in the letter. A software correction is under development and will be installed by a TAMS representative in the future.

Device

Magnetic Resonance Imaging Systems under the following names: || Visart || Excelart || Excelart P...
  • Model / Serial
    All serial numbers.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Magnetic Resonance Imaging Systems under the following names: || Visart || Excelart || Excelart P2 || Excelart P3 || Excelart SPIN || Excelart VANTAGE
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Manufacturer Address
    Toshiba American Med Sys Inc, 2441 Michelle Dr, Tustin CA 92781
  • Source
    USFDA