Recall Z-1412-2019— Elekta Instrument AB

Name: FDA recall Z-1412-2019
Creator: U.S. Food and Drug Administration
Published: 2018-06-27

Class II · Ongoing

Class II FDA medical device recall by Elekta Instrument AB, initiated 2018-06-27. It names one FDA 510(k) clearance: K173791. Product: Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.. Reason: The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume..

Recalling firm: Elekta Instrument AB
Classification: Class II
Status: Ongoing
Initiated: 2018-06-27
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K173791 — Leksell GammaPlanElekta Instrument AB·cleared 2018-02-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.