Events

Recall of Synergy XVI

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
    68255
  • Event Risk Class
    Class 2
  • Event Number
    Z-1724-2014
  • Event Initiated Date
    2014-04-23
  • Event Date Posted
    2014-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127224
  • 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
    Xvi can incorrectly calculate the target position of the treatment table.
  • Action
    Elekta is responsible for the correction of all products with this defect. 1. Notifications regarding the possibility of this software error and subsequent table location error and potential hazards have been sent out. The notifications include steps to take to reduce the possibility of the occurrence of an injury. 2. A software correction has been released for some versions of the XVI software. All versions of software with this error will be corrected by the end of July 2014. 3. The software correction will enable verification that values have been assigned to table position parameters; failure to pass verification will inhibit the system. The software correction will also detect internal communication errors (incomplete registrations) and inhibit the system when those errors are detected. 4. The update will be mandatory and will be made at no cost to the users. CDRH approves this CAP. You may proceed with implementation of the CAP. For further questions please call (770) 670-2422.

Device

Synergy XVI
  • Model / Serial
    XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.
  • Product Description
    Synergy XVI || Intended for radiation therapy treatment.
  • 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