Z-1412-2019Class II

Leksell GammaPlan 11.1

Name: Z-1412-2019 Leksell GammaPlan 11.1
Creator: Elekta Instrument AB
Published: 2018-06-27
License: https://open.fda.gov/license/

Elekta Instrument AB / initiated 2018-06-27 / Open, Classified / root cause: software

FDA source

Elekta Instrument AB began a recall of Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning on 2018-06-27. FDA classified it as Class II and gives the reason as "The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1412-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-06-27
Posted: 2019-05-23
Recalling firm: Elekta Instrument AB
Product: Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Root cause tag: software
FDA root cause: Software design
Action: Elekta initially notified customers on about 06/27/2018 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" LETTER. Instructions included to post the recall notice in a place accessible to all users, e.g. Instructions for Use, until the recall action is closed, advise the appropriate personnel working with the affected device of the recall and the content of the recall notification letter, and complete and return the Acknowledgement Form. Elekta updated their recall strategy on about 11/21/2018 and will be providing all affected customers with software upgrade 11.1.1. Electa service engineers will be pro-actively reaching out to customers to organize a date for installation on all affected devices. An updated recall notification was not sent to customers.
Quantity in commerce: 52 devices
Distribution: Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.
Product codes and lots: Software Version 11.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1412-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1412-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-29	2019-05-23

Product code IWB

K173791Class IILeksell GammaPlanElekta Instrument AB / cleared 2018-02-09

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)