Z-0312-2012

Elekta Leksell Gamma Knife C 1.2, 4 and 4C

Name: Z-0312-2012 Elekta Leksell Gamma Knife C 1.2, 4 and 4C
Creator: Elekta, Inc.
Published: 2011-05-26
License: https://open.fda.gov/license/

Elekta Limited / initiated 2011-05-26 / Terminated

FDA source

Elekta, Inc. began a recall of Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures on 2011-05-26. The reason FDA records is "Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0312-2012
Status: Terminated
Initiated: 2011-05-26
Posted: 2011-11-30
Terminated: 2014-10-06
Recalling firm: Elekta Limited
Product: Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.
FDA root cause: Pending
Action: Elekta sent an IMPORTANT NOTICE: Urgent Field Safety Notice letter dated May 12, 2011 to affected customers. The notice identified the affected product, problem, and actions to be taken by the user. The letter describes special care to be used in operating the helmet changer actuator LMR03. The letter states that Elekta will replace all actuators LMRO3. For more details contact your local Elekta representative. .
Quantity in commerce: 44
Distribution: Nationwide Distribution (USA) - including the states of: CA, CO, DAL, FL, GA, IL, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI and Puerto Rico
Product codes and lots: 4339, 4349, 5026, 4326, 5034, 4346, 4158, 4307, 4337, 4327, 4340, 5023, 5035, 5036, 4329, 4306, 4365, 4357, 5022, 4363, 4354, 4302, 4333, 4309, 4366, 4351, 4342, 4315, 4352, 4353, 4328, 5000, 4314, 4338, 4303, 4207, 4332, 4322, 4343, 4321, 4334, 4358

Product code IWB

K984328Class IILeksell Gamma Knife Target System, Model 24001Elekta Instrument AB / cleared 1999-05-21

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)