Elekta, Inc. Leksell SurgiPlan Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leksell SurgiPlan
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
US68104248, SG50425261, US68154313, US66320311, 3415G15729, 3416G05185, SW ONLY, 3416G07810, 3416G08464, US19311023, SG5121735, SG44720158, 000000000000010, SG33221023, 000000000000015, SG41020267, US19477688, SG14720637, SG31020878, SG21220437, IE24488098, SG11720734, US6836799, SG20220679, US68064889, US19344670, SG41720337, SG44820136, US6863578, US68247174, SG20220701, 000000000000011, 6458A30012, HP715/80, 000000000000019, 3628G06513, SG5020708, SG31120383, LGP-SG13420315, 000000000000014, 00000000000004, 3711C04231, US68154724, C160, SG33820630, 00000000000002, 000000000000013, 6146A06124, SG41920535, 6513A30173, 0304011939, A4986A, SG20220694, 000000000000016, SG20220699, 6601A30228, US19476876
Products Sold
US68104248, SG50425261, US68154313, US66320311, 3415G15729, 3416G05185, SW ONLY, 3416G07810, 3416G08464, US19311023, SG5121735, SG44720158, 000000000000010, SG33221023, 000000000000015, SG41020267, US19477688, SG14720637, SG31020878, SG21220437, IE24488098, SG11720734, US6836799, SG20220679, US68064889, US19344670, SG41720337, SG44820136, US6863578, US68247174, SG20220701, 000000000000011, 6458A30012, HP715/80, 000000000000019, 3628G06513, SG5020708, SG31120383, LGP-SG13420315, 000000000000014, 00000000000004, 3711C04231, US68154724, C160, SG33820630, 00000000000002, 000000000000013, 6146A06124, SG41920535, 6513A30173, 0304011939, A4986A, SG20220694, 000000000000016, SG20220699, 6601A30228, US19476876
Elekta, Inc. is recalling Leksell SurgiPlan due to Images from a different patient can be imported without a warning for the user.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Images from a different patient can be imported without a warning for the user.
Recommended Action
Per FDA guidance
Phase I - A technical note for LGP and SPS describing the risk for importing wrong image files and including recommendations on how to reduce this risk has been written and distributed to users of both Leksell GammaPlan and Leksell SurgiPlan on May 23, 2005 via FCO DOC 05-0001. Phase 2 - A maintenance release was created of the Scanner Interface (SIF) to correct the problem. This was distributed to Leksell SurgiPlan users on November 30, 2005 via FCO0000153-1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or After Sales gustaf.piehl AT elekta.com..
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