Class 2 Device Recall The Elekta Synergy System

• Date Initiated by Firm: May 06, 2011
• Date Posted: August 29, 2011
• Recall Status: Terminated on October 02, 2012
• Recall Number: Z-3079-2011
• Recall Event ID: 58874
• 510(K)Number: K032996 K051932 K963624
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Elekta, Inc.; 4775 Peachtree Industrial Blvd; Bldg 300, #300; Norcross GA 30092-3011
• For Additional Information Contact: Thomas Valentine; 770-670-2548
• Manufacturer Reason for Recall: A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.
• FDA Determined Cause: Other
• Action: ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified.
• Quantity in Commerce: 368
• Distribution: Nationwide and Puerto Rico

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = and Original Applicant = ELEKTA ONCOLOGY SYSTEMS, LTD.; 510(K)s with Product Code = and Original Applicant = ELEKTA, INC; 510(K)s with Product Code = and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.