Recall Z-0885-2013— Elekta, Inc.

Name: FDA recall Z-0885-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-18

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-01-18, terminated 2014-05-08. It names one FDA 510(k) clearance: K111676. Product: Elekta, Apex add-on Micro MLC, collimator for radiation therapy.. Reason: If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-18
Terminated: 2014-05-08
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K111676 — APEXElekta Limited·cleared 2011-09-30

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

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

Reason for recall

If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

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