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U.S. Department of Health and Human Services

Class 2 Device Recall Precise Treatment Table

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 Class 2 Device Recall Precise Treatment Tablesee related information
Date Initiated by FirmMarch 14, 2013
Date PostedApril 09, 2013
Recall Status1 Terminated 3 on March 17, 2015
Recall NumberZ-1072-2013
Recall Event ID 64664
510(K)NumberK983678 
Product Classification Couch, radiation therapy, powered - Product Code JAI
ProductPrecise Treatment Table. To be used as part of radiation therapy treatment process.
Code Information 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
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information ContactLinda Wetsel
770-300-9725
Manufacturer Reason
for Recall		The Column rotation can accidentally be moved to a different position which in the locked position.
FDA Determined
Cause 2		Device Design
ActionElekta 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 in Commerce443
DistributionNationwide Distribution and Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAI
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