Events

Recall of Device Recall Agility

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
    62915
  • Event Risk Class
    Class 2
  • Event Number
    Z-2340-2012
  • Event Initiated Date
    2012-07-27
  • Event Date Posted
    2012-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112031
  • 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
    Information released with the product agility did not originally contain information on compatibility with the add-on dynamic multileaf collimator apex.
  • Action
    ELEKTA sent an Important Field Safety Notice, FCO Ref: 20001405000 dated July 7, 2012, to current Agility users and a separate notice FCO Ref: 20001407026 for current Apex users who may be in the process of considering an upgrade to Agility. Both notices made it clear that Apex has not been integrated or classified as compatible for use with Agility. Users are advised not to use Apex with Agility. For questions regarding this recall call 770-300-9725.

Device

Device Recall Agility
  • Model / Serial
    152599 and 152678
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including DC & MD
  • Product Description
    Multileaf Collimator || To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA