Recall of Device Recall Leksell GammaPlan

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Radionuclide Radiation Therapy System - Product Code IWB
  • Reason
    Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.
  • Action
    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.


  • Model / Serial
    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.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution
  • Product Description
    Leksell GammaPlan, Model 5.34. || Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.
  • Manufacturer


  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
  • Source