Events

Recall of Device Recall TSXIOI: AQUILION 32/64; 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
    64667
  • Event Risk Class
    Class 2
  • Event Number
    Z-1067-2013
  • Event Initiated Date
    2011-11-30
  • Event Date Posted
    2013-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116738
  • 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
    The firm initiated this recall due to a potential software issue. the dlp (dose length product) value may be displayed incorrectly when the vhp option is used.
  • Action
    Toshiba sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter contained a return reply form that is to be faxed to TAMS for retention. Contact the firm at (800) 421-1968 for questions relating to this letter.

Device

Device Recall TSXIOI: AQUILION 32/64; System
  • Model / Serial
    Serial Numbers: HDA0722595 JDA0972130 JDA0972135 JDA0992147 JDA09Y2158 KDA09X2063 JDA09Y2157 JDA09Y2161 JDA1012171 JDA10X2191 JDA10X2197 JDA10Z2214 JGAl112220 JLA1122232 JLA1132235 JDAl112216 JDAl112219 NLA0972032 JDA1182242 JDA1182241 JDA1182244 JDA1072183 JDA1082189
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.
  • Product Description
    TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. || Designed to produce cross-sectional images of a human body.
  • 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