Events

Recall of Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device

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
    34955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0533-06
  • Event Initiated Date
    2006-02-23
  • Event Date Posted
    2006-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45009
  • 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, Image Processing, Radiological - Product Code LLZ
  • Reason
    When the error condition occurs the x-ray exposures will terminate immediately. the digital system (eps-plus/adr-1000a) will immediately stop acquiring images or will continue to acquire blank images. the remote console will lock-up upon release of the hand switch. the operator must reboot the system. this will result in the loss of the images acquired during the contrast portion of the study.
  • Action
    Recall letter to be sent to to customers of affected devices beginning February 23, 2006. Corrected software to be issued by Toshiba America Medical Systems Inc, for all affected devices.

Device

Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2...
  • Model / Serial
    Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to AZ, CA, FL, MT, & PA
  • Product Description
    Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
  • 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