Events

Recall of Device Recall MOSAIQ

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
    69656
  • Event Risk Class
    Class 2
  • Event Number
    Z-0221-2015
  • Event Initiated Date
    2014-11-03
  • Event Date Posted
    2014-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131263
  • 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
    A problem can exist in mosaiq resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
  • Action
    Elekta sent an Urgent Important Field Safety Notice letter to alert customers of the issue. This notice was distributed on November 3, 2014. A fix to the defect has been developed and has been released by Product Creation. For question call 408-830-8000.

Device

Device Recall MOSAIQ
  • Model / Serial
    MOSAIQ Release 2.60.257
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA
  • Product Description
    MOSAIQ || Product Usage: || MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
  • 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