Elekta, Inc. Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135065, 135068, 135071, 135072, 135073, 135076, 135079, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135144, 135150, 135151, 135157, 135158, 135163, 135164, 135167, 135168, 135170, 135172, 137173, 135175, 135177, 135181, 135182, 135184, 135189, 135191, 135190, 135192, 135195, 135196, 135199, 135200, 135206, 135207, 135208, 135209, 135210, 135211, 135215, 135216, 135224, 135225, 135226, 135227, 135230, 135233, 135237, 135241, 135247, 135251, 135256, 135258, 135262, 135271, 135272, 135274, 135277, 135278, 135282, 135285, 135296, 135298, 135303, 135306, 135313, 135323, 135324, 151008, 151024, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151390, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446, and 151479.
Products Sold
135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135065, 135068, 135071, 135072, 135073, 135076, 135079, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135144, 135150, 135151, 135157, 135158, 135163, 135164, 135167, 135168, 135170, 135172, 137173, 135175, 135177, 135181, 135182, 135184, 135189, 135191, 135190, 135192, 135195, 135196, 135199, 135200, 135206, 135207, 135208, 135209, 135210, 135211, 135215, 135216, 135224, 135225, 135226, 135227, 135230, 135233, 135237, 135241, 135247, 135251, 135256, 135258, 135262, 135271, 135272, 135274, 135277, 135278, 135282, 135285, 135296, 135298, 135303, 135306, 135313,135323, 135324, 151008, 151024, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151390, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446, and 151479.
Elekta, Inc. is recalling Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases due to Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.
Recommended Action
Per FDA guidance
An Important Notice A319 "Instructions for Use for Elekta Synergy kV Source Touchguard" dated 3/18/08 is in distribution to all affected customers. This letter identified the product and asked customers to file the Notice in the User Notice section of the appropriate User Manual. It also asked them to follow the instructions and the reason for the Notice. Questions should be directed to a local Elekta representative. Field Change Order (FCO) 514 259 "kV Source touchguard for systems with touchguard ready source covers" dated 10/17/08 was sent to all affected customers. FCO 514 260 "kV Source touchguard for systems with the original source covers" dated 10/17/08 was sent to all affected customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026