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
    58270
  • Event Risk Class
    Class 2
  • Event Number
    Z-2604-2011
  • Event Initiated Date
    2010-05-19
  • Event Date Posted
    2011-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98844
  • 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
    Radiation Treatment Planning System - Product Code MUJ
  • Reason
    Xio software: when a treatment machine is defined in source file maintenance (sfm), the mlc model is set to elekta, and beams using this treatment machine are added to a new plan in teletherapy, xio automatically adds an mlc to the beam. this is because the elekta linac will always have an mlc in place when the plan is actually delivered.
  • Action
    A Safety Notice, dated 5/20/10, was sent to Elekta / Computerized Medical Systems Inc clients in May 2010. The notice indicates the problem, the clinical impact. The notice states a future XiO Release will resolve the issue. A return postcard is included with the mailing to verify consignee received the notice. For sites not returning the postcard by 5/28/10, the recalling firm will contact them via phone or email to confirm receipt of the notice. The notice also informed the consignees they would be contacted when a solution was available.

Device

Device Recall XiO Radiation Treatment Planning System
  • Model / Serial
    XiO Release 4.50.00 and above
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and Government consignees. Foreign distribution was made to Australia, Belgium, Brazil, Canada, Colombia, France, India, Ireland, Israel, Italy, Malaysia, Netherlands, Philippines, Poland, Spain, and United Kingdom.
  • Product Description
    XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
  • 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