Z-0307-2012

Elekta Leksell Gamma Plan

Name: Z-0307-2012 Elekta Leksell Gamma Plan
Creator: Elekta, Inc.
Published: 2011-06-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2011-06-23 / Terminated / root cause: labeling and UDI

FDA source

Elekta, Inc. began a recall of Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning on 2011-06-23. The reason FDA records is "There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0307-2012
Status: Terminated
Initiated: 2011-06-23
Posted: 2011-11-30
Terminated: 2012-01-31
Recalling firm: Elekta Limited
Product: Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.
Quantity in commerce: 2
Distribution: Nationwide Distribution (USA) - including the states of: NM and WA
Product codes and lots: 6107 and 6115

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)