FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.
- Recall number
- Z-1251-2011
- Recalling firm
- Elekta, Inc.
- Product
- Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.
- Status
- Terminated
- Initiated
- 2009-10-02
- Posted
- 2011-02-15
- Terminated
- 2011-02-17
- Reason
- New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.
- Root cause
- Labeling design
- 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.
- Quantity
- 379 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K972324"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1037831
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28