Recall of Elekta Leksell Stereotactic System

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Stereotactic System - Product Code HAW
  • Reason
    New protocols for mr sequences may result in higher rf energies deposited during mr scanning, generating heat in uninsulated fixation posts.
  • Action
    Elekta sent Important Notice Affected Product: Fixation Posts, A331, dated June 22, 2009. The Important Notice will be added to the Customer User manual upon receipt.


  • Model / Serial
    GFD259, GFD129, GFD729, GFD708, GND229, GND116, GFD296, GFD201, GND83, GFD815, GFD2127, GFD2128, GFD2130, GFD2131, GND148, GFD06, GND44, GFD621, GFD352, GND157, GND181, GFD312, GFD106, GFD351, GND79, GFD1000, GFD1001, GFD249, GFD2247, GFD2265, GFD874, GND227, GND55, GFD529, GFD770, 9903005129, GND223, GFD216, GFD416, GFD915, GFD908, SH00208, SH00226, GFD688,M GFD746, GND246, GFD526, GFD571, GFD976, GFD633, GFD879, GFD919, GFD1013, GFD841, GFD869, GFD979, GFD12, GFD808, GFD524, GFD940, GFD271, GFD517, GFD760, GFD327, GND176, GFD780, GFD779, GFD412, GFD634, GFD42, GFD700, GND184, GFD538, GND76, GFD280, GND39, GFD109, GFD337, GND208, GFD65, GFD481, GFD212, GFD870, GFD792, GND24, GFD817, GFD776, GFD81, GND30, GFD163, GFD21, GND45, GND62, GFD1164, GFD861, GFD862, GFD1053, GFD1057, SH00008, SH0013, SH0033, GFD2316, GFD2318, GND147, GFD938, GFD657, GFD920, GFD924, GND109, GFD18, GFD494, GFD495, GND230, GFD559, GFD707, GFD692, GFD966, GFD968, GFD165, GFD133, GFD522, GFD520, GFD523, GFD762, GFD821, GND258, GFD43, GFD0054, GFD0055, GND178, GND36, GFD358, GFD256, GND80, GFD1076, GFD138, GFD617, GFD184, GFD194, GFD130, GFD96, GFD2174, GFD2272, GFD1062, GFD140, GFD117, GFD264, GND65, 9906005540, GFD804, GND165, GFD823, GFD1060, GFD101, GFD189, GND60, GFD137, GND94, GFD1066, GND216, GFD689, GFD223, GFD83, GFD99, GFD381, GFD706, FD662, GFD664, GFD237, GND185, GFD845, GFD26, GND126, GFD277, GFD284, GFD2245, GFD2246, GND135, GFD50, GFD200, GFD228, GFD2270, GFD2221, GND233, GND264, GFD671, GFD343, GFD91, GFD652, GFD281, GFD414, GND231, GND71, GFD120, GFD582, GFD690, GFD696, GFD697, GFD878, GFD71, GFD360, GFD368, GND40, GFD17, GFD658, GFD152, GFD660, GFD893, GND200, GFD831, GFD850, GFD69, GND122, GFD840, GFD698, GFD709, GND48, GND152, GND52, GFD1080, GFD809, GFD1059, GFD2264, GFD2229, GND192, GFD145, GFD820, GFD198, GFD188, GND172, GFD822, GND16, GND57, GFD41, GFD912, GFD917, GFD267, GFD998, GFD247, GFD255, GND10, GND123, GND31, GFD68, GFD632, GFD74, GFD934, GND159, GFD239, GFD261, GFD235, GFD521, GFD613, GFD399, GFD161, GND47, GFD843, GFD863, GFD865, SHO0165, GFD190, GFD816, GFD328, GFD557, GFD558, GND190, GFD19, 000000000000002, GFD824, GND27, GFD618, GND226, GND35, GND134, GND41, GND238, GFD257, GFD132, GFD543, 9904005345, GFD555, GFD143, GFD1000, GFD300, GND215, GND108, GFD586, GFD288, GND250, GFD033, GFD218, GND221, GND224, GFD107, GFD832, GFD278, GFD295, GFD1005, GFD725, GFD573, GFD667, GFD680, GFD956, GND194, GFD1971, GFD630, GFD587, GND28, SH00159, SH00160, GFD361, GFD370, GFD619, GFD620, GFD384, GFD156, GFD362, GFD914, GFD301, GFD1054, GND263, GFD733, GFD735, GFD913, GND189, GND167, GFD909, GFD376, GFD116, GFD903, GFD699, GFD317, GND161, GFD906, GFD186, GND193, GFD58, GFD234, GFD519, GND89, GFD730, GND261, GFD527, GFD391, GFD250, GFD763, GFD103, GFD483, GFD51, GND63, GND86, GFD778, GFD82, GFD948, GFD382, GFD747, GFD825, GFD556, GND75, GFD480, 9902005057, GND245, GND191, GND269, GND111, GFD205, GND84, GND170, GFD67, GFD232, GND96, GND100, GND22, GFD554, GND49, GND17, GFD2249, GFD2260, GFD1946
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.
  • Manufacturer


  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
  • Source