Events

Recall of Device Recall RT Desktop

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
    67217
  • Event Risk Class
    Class 2
  • Event Number
    Z-1081-2014
  • Event Initiated Date
    2013-11-25
  • Event Date Posted
    2014-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125019
  • 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
    During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
  • Action
    Elekta sent an Important Field Safety Notice November 2013 to all affected customers. Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 041 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Important Field Safety Notice is in the process of being distributed to customers advising them of the recommended Quality Assurance checks to avoid/detect the problem. The permanent solution to this problem is currently been developed. Corrective Action #2 - Permanent Solution - All users of Desktop Pro software will be informed of a mandatory upgrade to Integrity 1.2 upon its release which will prevent calibration from being inverted. For questions regarding this recall call 770-300-9725.

Device

Device Recall RT Desktop
  • Model / Serial
    R4.2, R5.0, R5.1, R6.0, R6.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen.
  • Product Description
    RT Desktop || The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • 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