Events

Recall of Device Recall Elekta Synergy XVI Medical Linear 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
    55101
  • Event Risk Class
    Class 2
  • Event Number
    Z-1405-2010
  • Event Initiated Date
    2008-12-12
  • Event Date Posted
    2010-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89894
  • 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
    It is possible that two (or more) ct reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
  • Action
    Elekta, Inc. issued an "Important Notice" dated December 12, 2008. Customers were informed of the affected device and instructed on proper steps until an update is provided. For further information, contact Elekta, Inc. at 1-770-300-9725.

Device

Device Recall Elekta Synergy XVI Medical Linear Accelerator
  • Model / Serial
    Serial Numbers: 151008, 151024, 151025, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446 and 151479.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AL, AZ, CO, CT, FL, GA, ID, KS, KY, MA, MI, MN, MS, NE, NY, OH, OK, OR, PA, TN, TX, VA, WA and WV.
  • Product Description
    Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. || Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • 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