CLASS II ONGOING Device recall · Reported 29 May 2019 · FDA Enforcement Report

Leksell GammaPlan recalled by Elekta Instrument AB

Elekta Instrument AB is recalling Leksell GammaPlan 11.1, distributed nationwide in the US. The recall was initiated on 27 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Version 11.1

Quantity recalled52 devices

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-1412-2019
FDA event ID: 82662
Recalling firm: Elekta Instrument AB, Stockholm, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jun 2018
FDA classified: 23 May 2019
Reported: 29 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Jun 2018	Recall initiated by company
23 May 2019	Classified by FDA	+330 days
29 May 2019	Published in enforcement report	+6 days

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

Reason for recall

The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

Product as listed by the FDA

Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

Where it was distributed

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.

Nationwide Georgia Maryland New Jersey Pennsylvania Puerto Rico Washington

Questions about this recall

Why was it recalled?

The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

Which lots are affected?

Software Version 11.1

Where was it sold?

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

More recalls from Elekta Instrument AB

All 5

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material	11 states
24 Apr 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material
5 Apr 2023Device	CLASS II	Instructions for Use for the following Leksell Stereotactic recalled	Elekta Instrument AB	Other	Nationwide
8 Jul 2020Device	CLASS II	Leksell Vantage Stereotactic System recalled by Elekta Instrument AB	Elekta Instrument AB	Device Malfunction	14 states

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