Events

Recall of Device Recall Precise Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57570
  • Event Risk Class
    Class 2
  • Event Number
    Z-1030-2011
  • Event Initiated Date
    2008-03-10
  • Event Date Posted
    2011-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96671
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Couch, radiation therapy, powered - Product Code JAI
  • Reason
    Possible error in the table longitudinal position.
  • 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.

Device

Device Recall Precise Table
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Product Description
    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.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA