BEUDAMED
    FDA Enforcement Class II Terminated

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    Recall: Z-1065-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1065-2014
    Event ID
    65451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2014
    Initiation Date
    May 28, 2013
    Classification Date
    March 6, 2014
    Termination Date
    September 15, 2021
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    Reason

    Customers are resetting the default values outside recommended factory settings.

    Code Info

    151855, 151587, 152246, 151694, 152019, 105864, 151729, 105932, 151574, 152397, 152559, 152248, 151875, 153036, 153072, 151965, 151076, 151363, 152448, 105782, 151110, 105841, 105731, 105989, 152154, 151093, 151369, 105727, 151705, 151954, 152502, 152454, 152262, 151504, 105941, 151418, 105990, 151674, 105555, 151399, 105809, 151802, 105610, 151134, 151421, 105716, 105717, 152427, 105829, 153035, 105910, 152117, 152803, 151566, 151033, 152271, 151736, 151700, 151866, 151259, 151698, 151699, 151539, 151517, 151636, 151811, 105584, 151568, 152452, 151390, 152960, 151258, 151159, 152051, 153045, 151708, 152425, 151267, 152939, 152491, 105590, 151167, 105853, 105854, 152356, 152959, 151584, 151989, 105894, 151391, 151317, 151522, 105925, 151055, 151423, 151981, 151808, 152801, 152970, 151367, 151769, 151969, 153019, 153021, 151977, 151809, 152205, 151763, 151695, 151507, 151623, 151627, 105883, 105914, 151238, 152703, 151640, 152163, 151380, 151479, 152200, 152192, 151933, 152126, 152475, 152115, 152116, 152965, 151422, 152802, 152927, 152123, 105992, 105950, 151955, 151340, 153061, 151014, 151722, 152222, 151025, 151724, 151779, 152652, 152659, 152715, 152091, 105559, 105844, 151178, 152585, 105960, 151810, 151467, 151678, 151791, 152522, 151514, 152176, 151051, 151848, 151849, 151411, 153030, 151216, 151430, 151173, 151931, 151696, 152373, 151077, 152388, 151616, 151867, 151008, 151595, 152948, 151141, 151228, 152365, 151433, 151611, 152008, 105728, 152732, 151151, 152833, 151714, 105646, 152815, 152023, 151095, 105773, 105587, 105890, 152433, 152954, 151653, 152223, 152303, 152767, 152358, 151892, 151785, 105846, 152352, 152353, 152359, 152362, 152881, 151515, 105828, 151360, 151704, 151765, 151325, 152618, 105591, 151035, 151059, 151861, 152946, 105630, 151675, 152305, 152468, 152787, 151538, 152031, 152469, 152481, 152601, 153114, 105644, 151709, 151029, 105561, 151886, 151956, 105929, 151024, 151860, 151523, 151521, 105568, 105936, 151803, 153050, 105881, 105806, 151885, 105868, 151260, 151519, 151432, 151783, 152175, 152232, 152177, 152604, 151952, 152257, 152798, 151410, 153032, 105593, 151371, 151084, 151098, 152792, 105969, 151030, 151774, 152220, 151016, 152217, 105926, 105676, 105621, 151435, 151319, 151387, 151978, 151734, 152446, 105872, 151530, 105636, 151328, 152673, 151176, 152371, 151080, 152370, 151689, 105856, 105918, 151759, 151626, 151842, 151942, 151567, 151598, 151601, 151958, 151959, 151960, 152364, 151820, 152717, 105666, 151760, 105902, 105998, 105637, 151253, 151269, 151396, 151104, 151770, 151864, 105678, 105879, 151782, 152098, 151099, 151557, 151558, 151789, 152210, 152211, 105649, 151309, 152103, 152301, 105754, 105982, 151160, 151634, 152155, 152599, 152600, 152963, 151388, 151394, 151793, 105859, 105759, 151305, 105774, 151398, 151540, 151632, 151015, 152214, 152520, 152955, 105580, 151446, 151143, 152158, 151301, 151962, 152392, 105837, 151847, 105647, 105699, 105705, 105898, 151684, 152784, 105660, 151038, 152530, 151229, 152593, 151441, 152483, 152536, 105564, 105565, 153046, 105886, 151256, 152678, 153037, 151154, 151168, 151839, 151537, 151155, 151156, 151157, 151491, 151579, 105585, 152043, 151801, 105744, 105984, 151412, 105567, 151728, 153071, 151053, 151359, 105624, 152079, 152080, 105949, 152783, 152307, 152308, 105563, 105648, 105655, 151585, 105882, 151326, 151327, 151443, 152331, 151130, 151250, 151828, 151881, 151882, 151245, 105796, 105812, 152504, 105586, 151683, 151764, 105612, 151416, 105566, 152064, 151961, 152916, 151664, 151953, 105657, 151751, 152036, 151266, 152828, 152432, 151812, 151672, 151074, 152174, 105770, 105772, 105776, 151352, 151298, 105257, 105803, 151545, 151628, 152207, 152817, 152818, 105723, 151362, 151073, 153068, 152549, 151710

    Distribution

    USA Nationwide Distribution in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC and including Puerto Rico.

    Quantity

    472 units