Events

Recall of Device Recall Precise Treatment 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
    64664
  • Event Risk Class
    Class 2
  • Event Number
    Z-1072-2013
  • Event Initiated Date
    2013-03-14
  • Event Date Posted
    2013-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116734
  • 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
    The column rotation can accidentally be moved to a different position which in the locked position.
  • Action
    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.

Device

Device Recall Precise Treatment Table
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico.
  • Product Description
    Precise Treatment Table. || To be used as part of radiation therapy treatment process.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA