Events

Recall of Device Recall Aquilion CT System TSX301C

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
    71923
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2016
  • Event Initiated Date
    2015-05-08
  • Event Date Posted
    2015-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139354
  • 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
    If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
  • Action
    Toshiba America Medical Planned Action to bring defect into Compliance: a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Toshiba America Medical Systems, Inc. will implement this CAP by February 1, 2016. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.

Device

Device Recall Aquilion CT System TSX301C
  • Model / Serial
    system software V6.0 or later
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including Puerto Rico
  • Product Description
    Toshiba Aquilion CT System TSX-301C
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA