Events

Recall of Device Recall Elekta Synergy

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
    55098
  • Event Risk Class
    Class 2
  • Event Number
    Z-1441-2010
  • Event Initiated Date
    2008-03-18
  • Event Date Posted
    2010-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89889
  • 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
    Medical Linear Accelerator - Product Code IYE
  • Reason
    Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.
  • Action
    An Important Notice A319 "Instructions for Use for Elekta Synergy kV Source Touchguard" dated 3/18/08 is in distribution to all affected customers. This letter identified the product and asked customers to file the Notice in the User Notice section of the appropriate User Manual. It also asked them to follow the instructions and the reason for the Notice. Questions should be directed to a local Elekta representative. Field Change Order (FCO) 514 259 "kV Source touchguard for systems with touchguard ready source covers" dated 10/17/08 was sent to all affected customers. FCO 514 260 "kV Source touchguard for systems with the original source covers" dated 10/17/08 was sent to all affected customers.

Device

Device Recall Elekta Synergy
  • Model / Serial
    135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135065, 135068, 135071, 135072, 135073, 135076, 135079, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135144, 135150, 135151, 135157, 135158, 135163, 135164, 135167, 135168, 135170, 135172, 137173, 135175, 135177, 135181, 135182, 135184, 135189, 135191, 135190, 135192, 135195, 135196, 135199, 135200, 135206, 135207, 135208, 135209, 135210, 135211, 135215, 135216, 135224, 135225, 135226, 135227, 135230, 135233, 135237, 135241, 135247, 135251, 135256, 135258, 135262, 135271, 135272, 135274, 135277, 135278, 135282, 135285, 135296, 135298, 135303, 135306, 135313,135323, 135324, 151008, 151024, 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, 151390, 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 -- Including Puerto Rico.
  • Product Description
    Elekta Synergy || Intended to be used for radiation therapy treatment of malignant neoplastic diseases.
  • 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