Recall Z-1244-2015— Elekta, Inc.

Name: FDA recall Z-1244-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2014-12-19, terminated 2017-08-07. It names one FDA 510(k) clearance: K013112. Product: Focal Sim radiation therapy treatment planning system. Reason: Incorrect CT to ED when using the Monaco Image Statistics Tool..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2017-08-07
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K013112 — FOCAL SIMComputerized Medical Systems, Inc.·cleared 2001-12-05

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

Focal Sim radiation therapy treatment planning system

Reason for recall

Incorrect CT to ED when using the Monaco Image Statistics Tool.

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