Recall Z-1719-2015— Elekta, Inc.

Name: FDA recall Z-1719-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-01

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2015-06-01, terminated 2016-01-12. It names one FDA 510(k) clearance: K103093. Product: Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.. Reason: Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-01
Terminated: 2016-01-12
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K103093 — LEKSELL GAMMAPLANElekta Instrument AB·cleared 2010-12-21

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

Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.

Reason for recall

Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

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