Z-1030-2011
Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and...
Elekta Limited / initiated 2008-03-10 / Terminated
Elekta, Inc. began a recall of Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and... on . The reason FDA records is "Possible error in the table longitudinal position". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1030-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Elekta Limited
- 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.
- Product code
- JAI Couch, Radiation Therapy, Powered
- Reason for recall
- Possible error in the table longitudinal position.
- FDA 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 in commerce
- 597 units
- Distribution
- Nationwide Distribution and Puerto Rico
- Product codes and lots
- 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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
