Recall Z-1085-2014— Elekta, Inc.

Name: FDA recall Z-1085-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-25

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-11-25, terminated 2017-11-08. It names one FDA 510(k) clearance: K123808. Product: Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.. Reason: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Terminated: 2017-11-08
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K123808 — AGILITYElekta , Ltd.·cleared 2013-04-04

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

Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.

Reason for recall

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

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