Events

Recall of 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
    63335
  • Event Risk Class
    Class 2
  • Event Number
    Z-0169-2013
  • Event Initiated Date
    2012-09-18
  • Event Date Posted
    2012-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113515
  • 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 patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in mosaiq.
  • Action
    The firm, MOSAIQ, sent an "IMPORTANT SAFETY NOTICE- LINMSQ0003" was sent to consignees/customers on September 18, 2012. The notice described the product, problem and actions to be taken. The customers were instructed to check their Department Setup configuration settings, and re-enable the Field Edit Delta Display feature if they have disabled it. Note: sites can take this action without an upgrade/patch. The customers were also instructed to complete and return the CONFIRMATION OF RECEIPT form via fax to: 702-992-5002 in US or +44 (0)1293 654401 in OUS, Attn: Elekta OIS Support; scan and email to: support@impac.com or europe.support@impac.com; Attn: Elekta OIS Support and/or mail to: C/O Elekta OIS Support, 2310 Corporate Circle, Suite 275, Henderson, NV, USA; or C/O Elekta OIS Support, Elekta Limited, Linac House, Fleming Way, Crawley, West Sussex, RH10 9RR, UK. (Note: Product upgrade/patch is not mandatory or even necessary to reduce the related risk.) For questions, concerns, and requests for upgrade, email: support@impac.com (North America and Rest of World) or europe.support@impac.com (Europe) or call Vice President of RA/QA RNA at 770-670-2548.

Device

Oncology Information System
  • Model / Serial
    Version 2.00 to 2.41
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of Canada.
  • Product Description
    MOSAIQ || MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA