Events

Recall of Device Recall Scanner, Computed Tomography, XRay

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
    62851
  • Event Risk Class
    Class 2
  • Event Number
    Z-2266-2012
  • Event Initiated Date
    2008-02-27
  • Event Date Posted
    2012-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111873
  • 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, computed system - Product Code JAK
  • Reason
    The systems all have a similar table control board. it has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. this is referred to as "free" mode in the operation manuals. if this error does occur it is possible that the patient could be scanned at an incorrect position.
  • Action
    Toshiba sent a "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to please avoid moving the table in the "Free" or manual mode as much as possible. If it is necessary to move the table in this manner please verify the table position prior to initiating the scan sequence. If it is noted that the position is not correct, exit the eXam plan and start a new one beginning with the scanoscopy. Please share this information with all users of the equipment and your clinical or biomedical engineering departments. Please find the attached customer reply form. The purpose of this form is for FDA tracking. Please take a moment to complete the form and fax it to the toll free number on the form.". The contact information for this recall is:"(800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.".

Device

Device Recall Scanner, Computed Tomography, XRay
  • Model / Serial
    Serial Number Range (last 4): (2665-3149), (2211-2237), (2057-2067), A3622041, A4582122 + (2690-3131), (2001-2171), (2001-2124), (2001-2255), (2001-3007), (2015-2061), (2001-2008).  The following Device Name/Model Number: Asteion Super 4 / TSX-021B Aquilion Super 4 / TSX-101A/7 Aquilion 8 / TSX-101A/F Aqui1ion 16/ TSX-101A/6 Aqui1ion 16/ TSX-101A/G Aquilion 32 / TSX-101A/D Aquilion 32 / TSX-101A/I Aquilion 64/TSX-101A/E Aquilion 64 / TSX-101AIH Aquilion 16 LB / TSX-201A AquilionONE / TSX-301A
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA ( Nationwide Distribution )
  • Product Description
    Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. || This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
  • 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