Events

Recall of Device Recall Toshiba

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
    28184
  • Event Risk Class
    Class 3
  • Event Number
    Z-0546-04
  • Event Initiated Date
    2004-01-27
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31342
  • 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 anomally causes image slices to be in incorrect order.
  • Action
    Firm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.

Device

Device Recall Toshiba
  • Model / Serial
    Flexart systems with software V3.51*R534 to V4.10*R551.  Visart systems with software V3.51*R234 to V4.10*R251.  Excelart systems with softare V4.04*R251 to V4.10*R271.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.
  • Product Description
    Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.
  • 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