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FDA Medical Device Recalls (openFDA)

Elekta, Inc.: Precise Treatment Table. To be used as part of radiation therapy treatment process.

Recall number
Z-1072-2013
Recalling firm
Elekta, Inc.
Product
Precise Treatment Table. To be used as part of radiation therapy treatment process.
Status
Terminated
Initiated
2013-03-14
Posted
2013-04-09
Terminated
2015-03-17
Reason
The Column rotation can accidentally be moved to a different position which in the locked position.
Root cause
Device Design
Action
Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Elekta office for questions about this notice.
Quantity
443
Distribution
Nationwide Distribution and Puerto Rico.
Lot, serial or model codes
151855, 151611, 152008, 151587. 151694, 152019, 105864, 105932, 151574, 151267, 152397, 152248, 152559, 151875, 151965, 151369, 152502, 105829, 152262, 151504, 151159, 105941, 151418, 151538, 105990, 151674, 105555, 151729, 151399, 105809, 151802, 151421, 152427, 129032, 105803, 152652. 152659, 152715, 152117, 152803, 151566, 152271, 151736, 151700, 105895, 151866, 151259, 151698, 151699, 151636, 151539, 152454, 151811, 105782, 152425, 151568, 105126, 151390, 152452, 151258, 152491, 105590, 151167, 105853, 105854, 152356, 151584, 105494, 151989, 151522, 151317, 105925, 151055, 151423, 151110, 151981, 151808, 151360, 152801, 151367, 151769, 151969, 105894, 152043, 151391, 151708, 151033, 151809, 151098, 151099, 105841, 152205, 105325, 151763, 151695, 151507, 152703, 105883, 105914, 151238, 151540, 151640, 152777, 152163, 151623, 151627, 151380, 151479, 152331, 152200, 152192, 105481, 151933, 152126, 152115, 152116, 152475, 151422, 152802, 152927, 152123, 151076, 151363, 151954, 105992, 151955, 151340, 105950, 151014, 105273, 152388, 151722, 105154, 105731, 152154, 105284, 151724, 151779, 105644, 152091, 105559, 105844, 151178, 151093, 152585, 105960, 151810, 151467, 151678, 152176, 151051, 151848, 151849, 151411, 151216, 151430, 151173, 151931, 151696, 151616, 151867, 105195, 151141, 151228, 151433, 151977, 105728, 152732, 152833, 105359, 151151, 151714, 105646, 129016, 152815, 152023, 105773, 105260, 105890, 152362, 152359, 152353, 152352, 152433, 105199, 151653, 152303, 152358, 151892, 152223, 152767, 105846, 152881, 151515, 151861, 152618, 105630, 151675, 105591, 151059, 152305, 151325, 152787, 152468, 152031, 152469, 152481, 152601, 151709, 151029, 151886, 151956, 151812, 105929, 151024, 151860, 151523, 105568, 105936, 129029, 151803, 105881, 105261, 105806, 129041, 151885, 105868, 151260, 151519, 151432, 151783, 152175, 152232, 152177, 152365, 151952, 152257, 105528, 152798, 151410, 151084, 105593, 151371, 151305, 105969, 151016, 152220, 151774, 152217, 105926, 151435, 151978, 151387, 151734, 151626, 151842, 105872, 151530, 105636, 129012, 151328, 152673, 151176, 152371, 151080, 152370, 152604, 105856, 151759, 151689, 151942, 151567, 151601, 151598, 151960, 151958, 151959, 152364, 152792, 151820, 152717, 151557, 151558, 105666, 151760, 105902, 105998, 129015, 151319, 105567, 151269, 151253, 151396, 151104, 105678, 105514, 105879, 151705, 151770, 105321, 152098, 152246, 151789, 152103, 151309, 152301, 152446, 105754, 151634, 105982, 151160, 152155, 152600, 152599, 151388, 151394, 151793, 105859, 105759, 152210, 152211, 151398, 151632, 151015, 152214, 105580, 151704, 151446, 152520, 151143, 152158, 151765, 151301, 151962, 151785, 105837, 152392, 151847, 105699, 105647, 105898, 151684, 152784, 151441, 105660, 129018, 151038, 152530, 151229, 152593, 105564, 152536, 152483, 105886, 151256, 152678, 105117, 151864, 151839, 151154, 151168, 151537, 151155, 151156, 151157, 151491, 105984, 151412, 151801, 105492, 151728, 105910, 151521, 151053, 151359, 152783, 152448, 152079, 152080, 105949, 152307, 152308, 105624, 105563, 151585, 105882, 151326, 151327, 151443, 151828, 151130, 151250, 151882, 151881, 105812, 105796, 151245, 105586, 151683, 151764, 152504, 129024, 151416, 152064, 152222, 152373, 151579, 151961, 105621, 105532, 151664, 151953, 105657, 151751, 152036, 105610, 151134, 151266, 152828, 152432, 151672, 151074, 151595, 151008, 152174, 105770, 105776, 105445, 151352, 151545, 152207, 151628, 105723, 151362, 151298, 105386, 151073, 152549, 151710, 151791, 151514, 152522
510(k) numbers
["K983678"]
PMA numbers
not on file
Product code
JAI
Firm FEI
1037831
Firm city
Atlanta
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

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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

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