Events

Recall of Oncentra Brachy 4.5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nucletron BV.

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
    78087
  • Event Risk Class
    Class 2
  • Event Number
    Z-0050-2018
  • Event Initiated Date
    2017-08-10
  • 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=158639
  • 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
    Incorrect source step size may occur in the software plans.
  • Action
    Elekta sent an Field Safety Notice notification dated August 2017, and was emailed to customers on August 10, 2017, informed users of the issue and workarounds that can be used to avoid the issue.The user is informed the issue will be resolved in a fix which will be released by the end of February 2018. Once released, the firm will proactively reach out to all affected customers to arrange a time to install the fix. An acknowledgement form was enclosed which the user was to complete to indicate they have read and understood the notice and accept implementation of any given recommendations. For further questions, please call (770) 670-2359.

Device

Oncentra Brachy 4.5
  • Model / Serial
    Versions 4.5, 4.5.1, and 4.5.2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution.
  • Product Description
    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. || Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
  • Manufacturer
    Nucletron BV

Manufacturer

Nucletron BV
  • Manufacturer Address
    Nucletron BV, Waardgelder 1, POBox 930, Veenendaal Netherlands
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA