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U.S. Department of Health and Human Services

Class 2 Device Recall Precise Table

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 Class 2 Device Recall Precise Tablesee related information
Date Initiated by FirmMarch 10, 2008
Date PostedFebruary 03, 2011
Recall Status1 Terminated 3 on August 09, 2012
Recall NumberZ-1030-2011
Recall Event ID 57570
510(K)NumberK983678 
Product Classification Couch, radiation therapy, powered - Product Code JAI
ProductPrecise 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.
Code Information 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   
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information ContactThomas Valentine
770-670-2548
Manufacturer Reason
for Recall		Possible error in the table longitudinal position.
FDA Determined
Cause 2		Other
ActionElekta 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 in Commerce597 units
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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