Events

Recall of Aquilion Lightning CT System

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
    73857
  • Event Risk Class
    Class 2
  • Event Number
    Z-1560-2016
  • Event Initiated Date
    2016-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145199
  • 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
    Toshiba american medical systems, inc. is recalling the tsx-035a because of a potential problem with the aquilion lightning ct system istation cover falling off of the gantry.
  • Action
    An Urgent Medical Device Correction letter dated 4/12/16 was sent to a customer to bring to the customer's attention with a potential problem with the Aquilion Lightning CT System iStation cover. The letter informs the customer that the iStation cover may come off due to deficient dimensional geomtry. The letter informs the customer of the problem identified and corrective action to be taken. The customer is instructed to complete and return the attached form and fax it to (877) 349-3054. If the customer has any questions regarding the recall letter, then the customer is instructed to contact Paul Biggins at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.

Device

Aquilion Lightning CT System
  • Model / Serial
    Serial No. 2DA15Y2036
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US in the state Nevada
  • Product Description
    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 || Product Usage: || Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
  • 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