Events

Recall of Device Recall XiO RTP 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
    58227
  • Event Risk Class
    Class 2
  • Event Number
    Z-2567-2011
  • Event Initiated Date
    2008-12-09
  • Event Date Posted
    2011-06-15
  • 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=98753
  • 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: under certain conditions, when the port shape is altered, dose is not recalculated. the port-change flag is not being set correctly when the port shape is regenerated. the dose distribution will not match the blocking displayed and the mis-match might not be obvious. monitor unit calculations will also be based on an incorrect dose distribution. this problem has existed since re.
  • Action
    Computerized Medical Systems, Inc. sent a "XiO CUSTOMER ADVISORY" letter dated December 8, 2008 to all affected customers. The advisory describes the product, problem, and the actions to be taken. The customers were instructed to set the prompt to "Yes" to avoid the problem from occurring according to written instructions provided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved with XiO Release 4.50.00. Questions should be directed to the manufacturer's representative at 408-830-8023.

Device

Device Recall XiO RTP System
  • Model / Serial
    XiO Release 4.3.1 through 4.40.00. All lot or serial numbers.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) including Puerto Rico and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Tajikistan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
  • Product Description
    XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. || 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