Events

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

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
    30420
  • Event Risk Class
    Class 2
  • Event Number
    Z-0273-05
  • Event Initiated Date
    2004-08-24
  • 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=35832
  • 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 patient identification number to be truncated.
  • Action
    Firm issued a letter notifying users of systems that when transferring image data to a DICOM server for any patient born on January 1, to verify that the Patient ID is correct on the DICOM server after the transfer. Firm will modify the software by January 2005.

Device

Magnetic Resonance Imaging Systems, under the following names: || Visart || Excelart || Excelart ...
  • Model / Serial
    No specific codes were listed.
  • 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
  • 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