Events

Recall of Device Recall TSX30IC: AQUlLlON ONE; System, XRay, Tomography, Computed.

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
    64673
  • Event Risk Class
    Class 2
  • Event Number
    Z-1068-2013
  • Event Initiated Date
    2012-11-14
  • Event Date Posted
    2013-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116744
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30ma, the control software may detect an error and perform error processing even though the x-ray output is normal.
  • Action
    Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any further questions regarding this letter please call (800) 521-1968.

Device

Device Recall TSX30IC: AQUlLlON ONE; System, XRay, Tomography, Computed.
  • Model / Serial
    Serial No: 1CB1262006
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the state of MD.
  • Product Description
    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
  • 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