Events

Recall of Device Recall Desktop Pro TM and Desktop Pro (VMAT)

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
    67223
  • Event Risk Class
    Class 2
  • Event Number
    Z-1082-2014
  • Event Initiated Date
    2013-11-25
  • Event Date Posted
    2014-03-06
  • 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=125026
  • 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
    Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 040 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. All software versions (r7.01) detailed in this notice are affected by this recall. 200 01 501 041 - Recommended quality assurance after a calibration procedure Released November 25, 2013. Only software versions R6.0 and R6.1 are affected by this recall. Important Field Safety Notices are 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.

Device

Device Recall Desktop Pro TM and Desktop Pro (VMAT)
  • Model / Serial
    Identifier - 6.0, 6.1.0, 7.0.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide): AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, including Puerto Rico, DC; and countries of: Albania, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia & Herzego, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore Slovakia, South Africa, South Korea, Spain, Sudan, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
  • Product Description
    Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
  • 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