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
    74668
  • Event Risk Class
    Class 2
  • Event Number
    Z-2293-2016
  • Event Initiated Date
    2016-07-15
  • 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=148151
  • 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
    Oncology Information System - Product Code IYE
  • Reason
    It is possible that a change to an order set will not be saved in the current open care plan. this can result in a wrong chemo dose in the order.
  • Action
    Elekta sent Important Field Safety Notice 371-03-MSQ-001 to all customers on 7/15/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. The letter also included a response form which is to be returned to Elekta.

Device

Device Recall MOSAIQ
  • Model / Serial
    Versions 2.50.05 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom
  • Product Description
    MOSAIQ Oncology Information System
  • 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