Events

Recall of Device Recall MOSAIQ(R) Oncology Information System

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
    77559
  • Event Risk Class
    Class 2
  • Event Number
    Z-2633-2017
  • Event Initiated Date
    2017-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156505
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Retention of outdated information in an order set. in the care plan library, double clicking to add or delete a component/procedure to an order set does not trigger the update of the associated care plans.
  • Action
    Elekta sent an Urgent Important Field Safety Notification letter dated June 2017. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. Customers are instructed that a copy of the Important Field Safety Notice is to be kept with the most current labelling and all personnel working with the product should be made aware of the content of the letter. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible but no longer than 30 days from receipt.

Device

Device Recall MOSAIQ(R) Oncology Information System
  • Model / Serial
    None
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of ANTIGUA AND BARBUDA, AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, CHEZ REPUBLIC, GERMANY, HUNGARY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, AND UK
  • Product Description
    MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher || Product Usage: || MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ¿ for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:  Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.  Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.  Import, view, annotate, adjust, enhance, manage and archive images.  Compare radiation treatment plans and evaluate dose coverage.  Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators.  Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ¿ reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.  View reference images to setup treatment. MOSAIQ¿ refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions.  Record actual delivered radiation values in an electronic chart to track treatment. MOSAIQ¿ is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
  • 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