Events

Recall of Device Recall Aquilion One: Aquilion TSX301B

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
    58031
  • Event Risk Class
    Class 2
  • Event Number
    Z-2896-2011
  • Event Initiated Date
    2011-01-07
  • Event Date Posted
    2011-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98287
  • 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
    X-ray Tomography System - Product Code JAK
  • Reason
    Toshiba america medical systems (tams) is initiating a field correction for the tsx-301a and tsx-301b: aquilion 64 system, x-ray, tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.
  • Action
    Toshiba America Medical Systems, Inc. sent an "Urgent Medical Device Correction" letter dated January 4, 2011 to all affected customers. The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system. For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.

Device

Device Recall Aquilion One: Aquilion TSX301B
  • Model / Serial
    1DA1062015, 1DB1072016, 1DB1082017, 1DB1082018, 1DB1082019
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA.
  • Product Description
    Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. || Toshiba American Medical Systems, Inc. || A multislice CT system that 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 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA