Events

Recall of ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5

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
    55099
  • Event Risk Class
    Class 2
  • Event Number
    Z-1411-2010
  • Event Initiated Date
    2007-09-19
  • Event Date Posted
    2010-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89892
  • 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 (with patient imaging) - Product Code IYE
  • Reason
    Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction.
  • Action
    The following Important Notices were sent to customers: 1) Important Notice A305-Possible Synergy XVI panel position error (dated September 19, 2007) was sent to customers with versions R3.5, R4.0 and R4.1., 2) Important Notice A306-Possible Synergy XVI panel positioning error (dated November 8, 2007) was released to encompass customers with version R4.2., and 3) Important Notice A328 dated March 10, 2009, and sent again on April 29, 2009, included a modification kit to address the original issue and an expanded range of serial numbers affected. This Important notice A328 entitled, Elekta Synergy kV Detector Position Readback Modification Kit supersedes A305 and A306 for customers who have serial numbers within the range specified. The letter describes the product and the problem and advises the customer to follow any instructions or recommendations covered in this Notice. If you have any questions, please contact Elekta at 770-670-2548.

Device

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
  • Model / Serial
    134351, 134524, 134723, 135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135068, 135071, 135072, 135073, 135076, 135078, 135079, 135081, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135104, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135133, 135142, 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, 135225, 135226, 135227, 135230, 135233, 135235, 135237, 135241, 135247, 135251, 135256, 135258, 135259, 135262, 135265, 135267, 135271, 135272, 135273, 135274, 135277, 135278, 135284, 135285, 135287, 135288, 135291, 135292, 135296, 135298, 135300, 135303, 135305, 135306, 135313, 135316, 135323, 135324, 135326, 135328, 135331, 135332, 135334, 135335, 135336, 135337, 135340, 135341, 135343, 135346, 135347, 135348, 135351, 135352, 135353, 135355, 135356, 135359, 135361, 135367, 135368, 135382, 135383, 135384, 135389, 135391, 135393, 135394, 135412, 135413, 135420, 135446, 135455, 136125, 136126, 136127, 136176, 136244
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Puerto Rico, Canada and Mexico.
  • Product Description
    Elekta Synergy XVI || The intended use: 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