Recall – Gamma Knife treatment planning overestimates volume margin

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

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