Elekta Instrument AB: Medical Device Recall in 2019 - (Recall #: Z-1412-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 27, 2018

Date Posted: May 29, 2019

Recall Number: Z-1412-2019

Event ID: 82662

Reason for Recall:

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

Status: Ongoing

Product Quantity: 52 devices

Code Information:

Software Version 11.1

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated