Events

Recall of Device Recall Angio WorkStation XIDFAWS801v6.00, v6.01, and V6.10 System: INFX8000V BiPlane 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
    74473
  • Event Risk Class
    Class 2
  • Event Number
    Z-2188-2016
  • Event Initiated Date
    2016-02-24
  • Event Date Posted
    2016-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147685
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    During a procedure the peak skin dose (psd) value was displayed on the dts larger than the dts expected value. it was found that the software incorrectly calculated the psd value when the x-ray condition of the frontal plane and the lateral plane are the same. it incorrectly used in the calculation a dose value from a previous exposure.
  • Action
    Toshiba Medical Systems (TAMS) planned action to bring product into Compliance: 1.TAMS will install the software and perform testing to ensure the software update was effective. 2. The customer notification letter which includes a statement that TAMS will, without charge, remedy the defect or bring the product into compliance. . If you have any questions regarding this, please feel free to contact your local Toshiba representative at (800) 521-1968.

Device

Device Recall Angio WorkStation XIDFAWS801v6.00, v6.01, and V6.10 System: INFX8000V BiPlane System
  • Model / Serial
    Model Number - XIDF-AWS801
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
  • Product Description
    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
  • 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