Events

Recall of Device Recall XiO Radiation Treatment Planning System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Computerized 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
    59102
  • Event Risk Class
    Class 2
  • Event Number
    Z-2919-2011
  • Event Initiated Date
    2011-06-09
  • Event Date Posted
    2011-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101149
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    The xio software currently prompts for entry of ct to ed data for a studyset. no indication is given that the electron density data should only be used for photon and electron calculations and either relative stopping power or mass density should be used for proton calculations (depending on the algorithm).
  • Action
    The firm, Eletka, Inc., issued an "Important Safety Notice" dated May 18, 2011 via mail to all affected sites. The notice explains the issue and identifies a work around to the problem until the new release is available. The customers were instructed to complete and return the enclosed "Confirmation of Receipt" form via FAX to 314-993-1175, attn: QA; e-mail or mail: CMS Software, Attn: QA, 13723 Riverport Drive, Suite 100, Maryland Heights, MO 63043. The notice states that "this problem has existed since XiO Release 2.4.0 and has been resolved in XiO Release 4.63.0 by adding warning messages and explanations to the XiO On-Line Help. Your site will be notified when this release is available." If you have any question, call 314-993-0003, 800-878-4267 or 408-830-8023.

Device

Device Recall XiO Radiation Treatment Planning System
  • Model / Serial
    XiO versions equal to or greater than 2.4.0 and less than 4.63.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including: IL, IN, MA, NJ and OK; and country of Germany.
  • Product Description
    XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 || The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Manufacturer Address
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA