Events

Recall of Device Recall TSX301A: AQUILION ONE

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
    56407
  • Event Risk Class
    Class 2
  • Event Number
    Z-1665-2011
  • Event Initiated Date
    2010-07-22
  • Event Date Posted
    2011-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93524
  • 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 america medical systems (tams) has found that communication may be cut off in the aquilion one/ premium systems, owing to the failure of a part used in the console.
  • Action
    The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to raffairs@tams.com. If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.

Device

Device Recall TSX301A: AQUILION ONE
  • Model / Serial
    Last 4 of serial number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2006, 2007, 2008, 2123, 2131, 2133, 2011, 2139, 2143, 2148, 2151, 2014, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2002, 2004, 2158, 2166, 2174
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.
  • Product Description
    TSX-301A: AQUILION ONE System || AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.
  • 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