Events

Recall of Device Recall Focal Sim

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
    70433
  • Event Risk Class
    Class 2
  • Event Number
    Z-1244-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133680
  • 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 ct to ed when using the monaco image statistics tool.
  • Action
    An Important User Notice (IUN 382-03-FCL-001) was issued to customers on 12/19/2014. The notice included a workaround to be used until a new software release. The notice also included an acknowledgement form to be returned.

Device

Device Recall Focal Sim
  • Model / Serial
    Focal Release 4.80
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.
  • Product Description
    Focal Sim radiation therapy treatment planning 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