Company: Elekta Instrument AB
Date of Enforcement Report: 5/29/2019
Class II
PRODUCT
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Recall Number: Z-1412-2019
REASON
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
RECALLING FIRM/MANUFACTURER
Elekta Instrument AB on 5/29/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
52 devices
DISTRIBUTION
US Nationwide and International