Skip to the content

FDA Medical Device Recalls (openFDA)

Elekta, Inc.: Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.

Recall number
Z-1030-2011
Recalling firm
Elekta, Inc.
Product
Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.
Status
Terminated
Initiated
2008-03-10
Posted
2011-02-03
Terminated
2012-08-09
Reason
Possible error in the table longitudinal position.
Root cause
Other
Action
Elekta sent an updated IMPORTANT NOTICE letter dated December 24, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Elekta recommended that all users, and Eleckta field service engineers do regular QA checks to compare the movement of the treatment table in a given axis with the digital readout. Elekta Service representatives would attach the screws with Loctite and calibrate the axis on these sites. For questions regarding this recall call 770-670-2548.
Quantity
597 units
Distribution
Nationwide Distribution and Puerto Rico
Lot, serial or model codes
124023, 124024, 124025, 124027, 124031, 124035, 124041, 124044, 124053, 124052, 124054, 124062, 124065, 124066, 124067, 124070, 124072, 124083, 124087, 124089, 124093, 124104, 124111, 124114, 124115, 124119, 124128, 124135, 124136, 124139, 124140, 124141, 124142, 124145, 124146, 124150, 124152, 124153, 124162, 124167, 124171, 124177, 124178, 124180, 124182, 124197, 124207, 124210, 124218, 124227, 124229, 124230, 124240, 124241, 124247, 124248, 124251, 124281, 124286, 124289, 124294, 124295, 124298, 124304, 124306, 124318, 124328, 124329, 124339, 124342, 124344, 124352, 124353, 124358, 124370, 124375, 124377, 124383, 124385, 124389, 124391, 124401, 124402, 124404, 124406, 124408, 124409, 124412, 124416, 124419, 124428, 124430, 124431, 124433, 124435, 124436, 124439, 124443, 124445, 124446, 124448, 124449, 124452, 124453, 124459, 124465, 124470, 124471, 124472, 124473, 124476, 124477, 124482, 124483, 124484, 124486, 124489, 124492, 124497, 124499, 124501, 124510, 124512, 125041, 125049, 125050, 125061, 125072, 125078, 125085, 125086, 125088, 125090, 125093, 125097, 125099, 125106, 125111, 125114, 125116, 125117, 125120, 125121, 125122, 125129, 125139, 125140, 124142, 125143, 125145, 125147, 125148, 125154, 125160, 125163, 125166, 125175, 125179, 125186, 125191, 125194, 125198, 125209, 125215, 125219, 125225, 125229, 125231, 125234, 125237, 125238, 125239, 125240, 125241, 125242, 125243, 125245, 125258, 125264, 125267, 125278, 125306, 125310, 125311, 125320, 125322, 125324, 125327, 125333, 125342, 125351, 125352, 125362, 125366, 125369, 125370, 125376, 125378, 125396, 125398, 125399, 125400, 125412, 125414, 125415, 125423, 125426, 125431, 125446, 125452, 125466, 125467, 125473, 125474, 125475, 125479, 125481, 125487, 125488, 125489, 125490, 125498, 125499, 125500, 125501, 125502, 125508, 125509, 125515, 125516, 125517, 125521, 125529, 125530, 125536, 125538, 125541, 125542, 125543, 125546, 125548, 125553, 125554, 125556, 125570, 125575, 125590, 125597, 125606, 125610, 125617, 125621, 125625, 125626, 125633, 125634, 125640, 125642, 125648, 125650, 125656, 125669, 125673, 125676, 125677, 125680, 125683, 125685, 125686, 125687, 125689, 125690, 125695, 125700, 125701, 125702, 125703, 125704, 125705, 125716, 125721, 125722, 125723, 125726, 125742, 125745, 125749, 125750, 125764, 125765, 125782, 125785, 125787, 125790, 125792, 125793,125797, 125799, 125800, 125801, 125812, 125816, 125817, 125823, 125825, 125826, 125828, 125830, 125831, 125837, 125839, 125849, 125852, 125855, 125858, 125869, 125875, 125876, 125888, 125889, 125893, 125899, 125906, 125912, 125920, 125928, 133807, 133808, 133815, 133820, 133825, 133827, 134008, 134027, 134040, 134046, 134047, 134048, 134062, 134070, 134073, 134075, 134078, 134081, 134090, 134091, 134092, 134094, 134104, 134115, 134118, 134126, 134129, 134130, 134137, 134138, 134140, 134143, 134154, 134157, 134169, 134172, 134183, 134189, 134192, 134194, 134195, 134196, 134197, 134200, 134206, 134211, 134212, 134213, 134219, 134234, 134235, 134236, 134237, 134239, 134241, 134249, 134250, 134251, 134254, 134256, 134258, 134259, 134269, 134275, 134280, 134292, 134295, 134303, 134307, 134318, 134319, 134321, 134322, 134324, 134328, 134329, 134331, 134336, 134348, 134354, 134358, 134368, 134375, 134378, 134380, 134382, 134383, 134388, 134391, 134395, 134396, 134399, 134401, 134427, 134428, 134430, 134432, 134436, 134438, 134441, 134445, 134456, 134457, 134458, 134465, 134469, 134472, 134473, 134475, 134483, 134503, 134519, 134535, 134561, 134563, 134564, 134565, 134571, 134595, 134597, 134603, 134605, 134606, 134615, 134621, 134626, 134629, 134630, 134631, 134652, 134667, 134671, 134673, 134679, 134701, 134704, 134706, 134708, 134709, 134711, 134729, 134748, 134750, 134754, 134768, 134770, 134772, 134772, 134781, 134787, 134804, 134819, 134822, 134860, 136009, 136012, 136015, 136034, 136036, 136046, 136047, 136049, 136059, 136063, 136064, 136065, 136069, 136071, 136074, 136075, 136080, 136081, 136083, 136084, 136086, 136087, 136089, 136092, 136096, 136097, 136100, 136106, 136107, 136108, 136109, 136110, 136118, 136119, 136137, 136147, 136152, 136153, 136156, 136157, 136163, 136165, 136169, 136172, 136175, 136178, 136181, 136195, 136197, 136200, 136222, 136234, 136240, 136241, 136243, 136251, 136252, 136257, 136257, 136258, 136267, 136269, 136270, 136285, 136286, 136291, 136292, 136293, 136294, 136298, 136310, 136312, 136313, 136315, 136317, 136318, 136319, 136322, 136330, 136332, 136337, 136338, 136340, 136342, 136350, 136364, 136368, 136373, 136379, 136381, 136390, 136393, 136396, 136397, 136409, 136418, 136422, 136431, 136433, 136439, 136450, 136446, 136459, 136462, 136463, 136468, 136471, 136472, 136476, 136491, 136492, 136498, 136500, 136516, 136519, 136522, 136523
510(k) numbers
["K983678"]
PMA numbers
not on file
Product code
JAI
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

Search this register