CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Laksell GammaPlan, a computer based dose planning system recalled

Elekta is recalling Laksell GammaPlan, a computer based dose planning system specifically designed for use, distributed nationwide in the US. The recall was initiated on 1 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware 10.2

Quantity recalled10

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1719-2015
FDA event ID: 71295
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 1 Jun 2015
FDA classified: 5 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Jun 2015	Recall initiated by company
5 Jun 2015	Classified by FDA	+4 days
17 Jun 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.

Nationwide Illinois Ohio Pennsylvania Texas Wisconsin

Questions about this recall

Is Laksell GammaPlan, a computer based dose planning system specifically designed for use recalled?

Yes. Elekta recalled Laksell GammaPlan, a computer based dose planning system specifically designed for use on 1 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-1719-2015.

Why was it recalled?

Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

Which lots are affected?

Software 10.2

Where was it sold?

Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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