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Devices
Device Recall The Elekta Synergy System
Model / Serial
151855, 151340, 151587, 152246, 151694, 105864, 105932, 105559, 151574, 152397, 151803, 151875, 151521, 151965, 151504, 151159, 105941, 151418, 151538, 105555, 151728, 151729, 151399, 105809, 151802, 151421, 105723, 105803, 151362, 151545, 151628, 151566, 152271, 151736, 151700, 151866, 151698, 151699, 151517, 151539, 151636, 151695, 151696, 151981, 105837, 151811, 105584, 151568, 151390, 151258, 151360, 151328, 105590, 151167, 151584, 151317, 151522, 105925, 151055, 151808, 151367, 151769, 151969, 151801, 151977, 105894, 151033, 151391, 151708, 152043, 151267, 151809, 152205, 152019, 151507, 105883, 105914, 151238, 151640, 152163, 151623, 151627, 151443, 151479, 152200, 152192, 151933, 152126, 152115, 152116, 151422, 152123, 151954, 105992, 105950, 151955, 152365, 151014, 151722, 151724, 151779, 151051, 151632, 105644, 152091, 105960, 151810, 151467, 151678, 151514, 151791, 152176, 152064, 151962, 151848, 151849, 151173, 151216, 151430, 151931, 105567, 105744, 105984, 151412, 151616, 151867, 151141, 151228, 152177, 151433, 151611, 152008, 105728, 151151, 105561, 151714, 105646, 152023, 105773, 105587, 105890, 151653, 151785, 151892, 152223, 152352, 152353, 152359, 152362, 151763, 151076, 151515, 105828, 151704, 151765, 151325, 151861, 151035, 151059, 105630, 151675, 105591, 105929, 151024, 151860, 152051, 152031, 105868, 105949, 151260, 151709, 151029, 105770, 105776, 105846, 105895, 151886, 151956, 151812, 151523, 105568, 105936, 105806, 151519, 152175, 152232, 152257, 151952, 151689, 151410, 151084, 105593, 151305, 151371, 105969, 151016, 151774, 152217, 152220, 151435, 105926, 151734, 105872, 151530, 105636, 151626, 151842, 151942, 151432, 151783, 151567, 151598, 151601, 151989, 151958, 151959, 151960, 151821, 151820, 105676, 151319, 151557, 151558, 151411, 151423, 105829, 105844, 151380, 151770, 151864, 105666, 151760, 105902, 105998, 105637, 151073, 151253, 151269, 151396, 151104, 105678, 105879, 105727, 105731, 105782, 105841, 151093, 151110, 151363, 151369, 151705, 152154, 151782, 151098, 151099, 151789, 105649, 151309, 152103, 152301, 151847, 105754, 105982, 151160, 151634, 151684, 151793, 151388, 151394, 105859, 151387, 151978, 152210, 152211, 151080, 152248, 151398, 152222, 151540, 151015, 152214, 151446, 105580, 151143, 152158, 151301, 152392, 105647, 105699, 105898, 151441, 105660, 151038, 151229, 105564, 105565, 152364, 105886, 151256, 151154, 151168, 151178, 151839, 151537, 151155, 151156, 151157, 151491, 105910, 152117, 105853, 105854, 105856, 151759, 151053, 151359, 105624, 151710, 152079, 152080, 105563, 105648, 105655, 151585, 105882, 151326, 151327, 151130, 151250, 151828, 151881, 151882, 105796, 105812, 151245, 152307, 152308, 152331, 105612, 151416, 151805, 152098, 151579, 151961, 105586, 151683, 151764, 105621, 151664, 151953, 105990, 151674, 105657, 101751, 152036, 151885, 105610, 151134, 151266, 151672, 151074, 151008, 151595, 152174, 151259, 151352, 152207, 151298
Product Classification
Radiology Devices
Distribution
Nationwide and Puerto Rico
Product Description
Elekta Synergy || The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Manufacturer
Elekta, Inc.
1 Event
Recall of Device Recall The Elekta Synergy System
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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
Language
English
Français
Español
한국어