Events

Recall of Device Recall Toshiba Infinixi

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
    58134
  • Event Risk Class
    Class 2
  • Event Number
    Z-1874-2011
  • Event Initiated Date
    2010-12-21
  • Event Date Posted
    2011-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98446
  • 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
    Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
  • Reason
    Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
  • Action
    An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.

Device

Device Recall Toshiba Infinixi
  • Model / Serial
    Software version 4.23.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Toshiba Infinix-i, DFP-8000D || The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the 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 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA