Events

Recall of Device Recall Model DMLC IVErgo, Dynamic Multileaf Collimator

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
    65309
  • Event Risk Class
    Class 2
  • Event Number
    Z-0978-2014
  • Event Initiated Date
    2013-05-01
  • Event Date Posted
    2014-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118524
  • 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
    Block, beam-shaping, radiation therapy - Product Code IXI
  • Reason
    It is possible for an intermittent error to occur in the gantry sensor of the dmlc iv systems.
  • Action
    Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422

Device

Device Recall Model DMLC IVErgo, Dynamic Multileaf Collimator
  • Model / Serial
    Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
  • Product Description
    DMLC IV-ERGO || Product Usage: || Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
  • 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