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
    58262
  • Event Risk Class
    Class 2
  • Event Number
    Z-2593-2011
  • Event Initiated Date
    2010-05-27
  • Event Date Posted
    2011-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98830
  • 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
    Xio software: the patient scan position is being confused with the treatment orientation of the patient. the patient scan position is determined from the data entered in pfm. subsequently, when a new teletherapy plan is created for a patient in teletherapy, the user is prompted with head/foot gantry on the text page. this prompt is asking for the orientation of the patient when they are treated.
  • Action
    Computerized Medical Systems Inc sent an undated Safety Notice to all affected customers. The notice indicated the problem, the clinical impact, and the workaround. The notice stated the sites will be notified when a solution is available.

Device

Device Recall XiO Radiation Treatment Planning System
  • Model / Serial
    XiO Release 2.1.0 and above
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
  • Product Description
    XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above || Used to create treatment plans for any cancer patient for who 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