Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1719-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 1, 2015

Date Posted: June 17, 2015

Recall Number: Z-1719-2015

Event ID: 71295

Reason for Recall:

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

Status: Terminated

Product Quantity: 10

Code Information:

Software 10.2

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated