Events

Recall of X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Med Sys 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
    31217
  • Event Risk Class
    Class 2
  • Event Number
    Z-0494-05
  • Event Initiated Date
    2004-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37400
  • 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
    Gauging - Product Code rad
  • Reason
    Non-compliance with radiation standards. incorrect display of the radiographic time, due to software anomaly.
  • Action
    Firm sent recall letters to customers and will be following up with field corrections which will be made on-site by the firm's own employees.

Device

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System D...
  • Model / Serial
    All Serial numbers in domestic distribution.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Manufacturer Address
    Toshiba American Med Sys Inc, 2441 Michelle Dr, Tustin CA 92781
  • Source
    USFDA