Elekta, Inc. Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Elekta, Inc. is recalling Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery us due to New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026