RecallRadar

FDA Device recall Z-1719-2015

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

On 2015-06-17 the FDA classified a Class II recall of Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment by Elekta, citing memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1719-2015
ClassificationClass II
Statusterminated
Initiated2015-06-01
Published2015-06-17
Last updated2026-09-13 11:53 UTC
CompanyElekta
DistributionUS

Product

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

Reason

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

Identifiers

code_infoSoftware 10.2

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1719-2015%22

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