FDA recall Z-1412-2019

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2018-06-27

Report date

2019-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2019