Z-1719-2015Class II

Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma...

Name: Z-1719-2015 Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma...
Creator: Elekta, Inc.
Published: 2015-06-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-06-01 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment on 2015-06-01. FDA classified it as Class II and gives the reason as "Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1719-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-01
Posted: 2015-06-05
Terminated: 2016-01-12
Recalling firm: Elekta Limited
Product: Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTICE 100-01-102-015" to all customers on 6/1/2015. The notice described the product, problem and actions to be taken. The customers were instructed to not use drag-and-drop to fuse images as a solution until a permanent fix can be developed and implemented on all affected devices. A solution is in development that will resolve the issue and is expected to be released September 2015. Elekta Service will then work with customers to implement on affected devices - estimated 6 month completion. Customers were also instructed to complete and return the IMPORTANT FIELD SAFETY NOTICE ACKNOWLEDGEMENT form to your local Elekta Office or Representative as soon as possible and within 30 days at the latest. If you have any queries about this Notice, please contact your local Elekta representative or the Global Post market Surveillance Manager at 770-300-9725 or email: [email protected].
Quantity in commerce: 10
Distribution: Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
Product codes and lots: Software 10.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1719-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1719-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-05

Product code IWB

K103093Class IILeksell GammaplanElekta Instrument AB / cleared 2010-12-21

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)