Elekta Synergy recallZ-3079-2011 · Elekta, Inc. · initiated May 6, 2011
Terminated All recalls posted in August 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-3079-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 6, 2011
- Posted by the FDA
- Aug 29, 2011
- Recalling firm
- Elekta, Inc.
- Quantity
- 368
- FDA submissions
- K032996, K051932, K963624
- 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.
Code information (models, lots, serial numbers)
Show the full code information (3k characters)
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
Other devices under the same FDA submission
1 device cleared under K032996, K051932, K963624 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 1525717Elekta Limited · Accelerator, linear, medical1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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