Recalls / —

—#116734

Product

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA product code

JAI — Couch, Radiation Therapy, Powered

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K983678

Affected lot / code info

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

Why it was recalled

The Column rotation can accidentally be moved to a different position which in the locked position.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

Nationwide Distribution and Puerto Rico.

Timeline

Recall initiated

2013-03-14

Posted by FDA

2013-04-09

Terminated

2015-03-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #116734. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.