Z-1223-2011

Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic...

Name: Z-1223-2011 Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic...
Creator: Elekta, Inc.
Published: 2005-10-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2005-10-01 / Terminated

FDA source

Elekta, Inc. began a recall of Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy on 2005-10-01. The reason FDA records is "Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1223-2011
Status: Terminated
Initiated: 2005-10-01
Posted: 2011-02-14
Terminated: 2011-03-02
Recalling firm: Elekta Limited
Product: Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.
FDA root cause: Other
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.
Quantity in commerce: 272 units
Distribution: Worldwide Distribution
Product codes and lots: 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 code IWB

K973441Class IILeksell GammaplanPatterson Consulting Group, Inc. / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)