Events

Recall of Elekta ERGO

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
    78665
  • Event Risk Class
    Class 2
  • Event Number
    Z-0234-2018
  • Event Initiated Date
    2017-09-01
  • 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=160084
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Incorrect dicom mapping of the exported collimator or couch angles from ergo, which would lead to incorrect rotation of the collimator or couch when using a mlc device for planning.
  • Action
    Elekta sent an Urgent Important Field Safety Notification letter dated September, 2017. The letter identified affected product, problem and actions to be taken. Customers were instructed that a copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers were asked to complete the verification tests and return the Important Field Safety Notice Acknowledgment form to their local Elekta representative as soon as possible but no later than 30 days from receipt. For questions contact your local Elekta Care Support Center.

Device

Elekta ERGO
  • Model / Serial
    Version 1.7.3 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of: AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ITALY, JAPAN, JORDAN, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM
  • Product Description
    Elekta ERGO++ || Product Usage: || ERGO is often used for stereotactic treatments.
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Manufacturer Address
    Elekta Inc, 13723 Riverport Dr Ste 100, Maryland Heights MO 63043-4819
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA