Events

Recall of Device Recall Oncentra External Beam Treatment Planning Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, 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
    72869
  • Event Risk Class
    Class 2
  • Event Number
    Z-0604-2016
  • Event Initiated Date
    2015-12-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142386
  • 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
    When using the option "tumor overlap fraction" in vmat planning it has been observed that in rare cases the system does include an organ at risk as target volume. this could result in open mlc, and open jaws in areas away from the target volume.
  • Action
    Elekta sent an Important Field Safety Notice 806-01-ETP-001 to all affected customers on December 18, 2015. The notice informs users of the issue and that should the issue occur it could result in overdosage of organs at risk outside the intended treatment volume. Users are strongly advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient. To prevent the issue from occurring, the workaround is to not use the Tumor Overlap Fraction for VMAT planning.and not to use the Tumor Overlap Fraction for VMAT planning. The issue will be solved in Oncentra External Beam version 4.5.2. The notice included an acknowledgement form which is to be returned to Elekta. For questions contact your local Elekta representative.

Device

Device Recall Oncentra External Beam Treatment Planning Software
  • Model / Serial
    Versions 3.3 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, NY, PA, and the countries of Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden and United Kingdom.
  • Product Description
    Oncentra External Beam - VMAT - Radiation therapy planning system || Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA