Events

Recall of Device Recall Desktop Pro Linear Medical Accelerator

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
    36967
  • Event Risk Class
    Class 3
  • Event Number
    Z-0421-2007
  • Event Initiated Date
    2006-11-23
  • Event Date Posted
    2007-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49684
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Reason
    Unexpected diaphragm movement when manual field size modifications are not saved.
  • Action
    Consignees were notified by letter on/about 11/23/2006

Device

Device Recall Desktop Pro Linear Medical Accelerator
  • Model / Serial
    Model number MRT 9871/ MRT 10601 (This issue affects Desktop Pro 6.0 and 6.1 users with a 3rd party R & V System, with the exception of Sigma Micro Users)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .
  • Product Description
    Desktop Pro¿ R6.0 & R6.1, Linear Medical Accelerator.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd., Building 300, Suite 300, Norcross GA 30092-3023
  • Source
    USFDA