Elekta, Inc. Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
SG33620363, US68537171, SG10821625, 3713G01281, SG03321319, SG33520213, US19502892, C160, SG0320704, SG44120295, 00000000000002, SG31630678, SG24820212, SG24820194, SG44221038, SG34620630, SG40920412, SG31020878, A4986A, SG11520160, SG44720158, SG41720310, SG43820213, 3416G09539, SG24820139, US19257221, SG33820630, 19476882, SG13320399H, SG40520126, SG50425261, SG41720317, US66320311, US19490144, SG21220130, US68154038, US19501776, SW ONLY, SG32520836, 3416G08464, SG21220113, SG44925638, SG04120289, SG51220179, SG2030679, US6824174, SG22920793, SG4820232, 3628G06513, 000000000000019, 00000000000004, US19310946, 3416G05185, US69131975, SG42520530, SG23320693, US68104248, SG23720396, SG24820231, SG14720637, SG43520759, US68513855, SG44820136, SG20220701, SG44120292, US19476874, US6863578, SG04020719, 3416G07810, SG43720660, SG44925635, US68538435, US19322820, SG33320960, US19319754, SG31620624, US10102906, SG44925637, SG43520477, US69172955, SG42720416, 3711C04231, US68154724, SG0620611, SG20220192, SG33620337, US19311023, SG35020182, US19239028, SG50425266, SG51920134, 000000000000011, SG44925633, SG24021335, 0304011939, A4986A, SG34220901, SG1220108, SG32120124, US69132547, SG43720550, US19476879, 6146A06124, SG41920535, 6412A00007, US68500234, US19322145, SG20220694, US68115508, SG41620718, SG10720353, 000000000000014, SG43520485, SG42820297, 000000000000015, SG41020267, US68104599, IE24488098, SG11421969, SG41720337, US6836799, US19344670, SG11720734, US68064889, SG20220679, 000000000000016, SG20220699, SG11421978, SG34220707, US19378673, SG34420200, SG20220143, SG50425271, US10025765, US90345020, US19345857, and SG13420315.
Products Sold
SG33620363, US68537171, SG10821625, 3713G01281, SG03321319, SG33520213, US19502892, C160, SG0320704, SG44120295, 00000000000002, SG31630678, SG24820212, SG24820194, SG44221038, SG34620630, SG40920412, SG31020878, A4986A, SG11520160, SG44720158, SG41720310, SG43820213, 3416G09539, SG24820139, US19257221, SG33820630, 19476882, SG13320399H, SG40520126, SG50425261, SG41720317, US66320311, US19490144, SG21220130, US68154038, US19501776, SW ONLY, SG32520836, 3416G08464, SG21220113, SG44925638, SG04120289, SG51220179, SG2030679, US6824174, SG22920793, SG4820232, 3628G06513, 000000000000019, 00000000000004, US19310946, 3416G05185, US69131975, SG42520530, SG23320693, US68104248, SG23720396, SG24820231, SG14720637, SG43520759, US68513855, SG44820136, SG20220701, SG44120292, US19476874, US6863578, SG04020719, 3416G07810, SG43720660, SG44925635, US68538435, US19322820, SG33320960, US19319754, SG31620624, US10102906, SG44925637, SG43520477, US69172955, SG42720416, 3711C04231, US68154724, SG0620611, SG20220192, SG33620337, US19311023, SG35020182, US19239028, SG50425266, SG51920134, 000000000000011, SG44925633, SG24021335, 0304011939, A4986A, SG34220901, SG1220108, SG32120124, US69132547, SG43720550, US19476879, 6146A06124, SG41920535, 6412A00007, US68500234, US19322145, SG20220694, US68115508, SG41620718, SG10720353, 000000000000014, SG43520485, SG42820297, 000000000000015, SG41020267, US68104599, IE24488098, SG11421969, SG41720337, US6836799, US19344670, SG11720734, US68064889, SG20220679, 000000000000016, SG20220699, SG11421978, SG34220707, US19378673, SG34420200, SG20220143, SG50425271, US10025765, US90345020, US19345857, and SG13420315.
Elekta, Inc. is recalling Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in ster due to Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.
Recommended Action
Per FDA guidance
Product bulletin Leksell GammaPlan - "Leksell GammaPlan version 5.34" (dated October 2005) was sent to affected Customers as notification of the problem. Field Change Order FCO-DCO-05-0006 (dated November 22, 2005) and Technical Notes Leksell GammaPlan Leksell SurgiPlan Important Notice - "Potential issue using flipped angiographic images" (dated October 2005) was sent to Elekta Service Engineers as notification of the problem. The letters described the issue and the FCO asked the Service Engineers to confirm their receipt of the documentation. The Technical Notes also discussed image visualization requirements and listed recommendations.
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