Recall Z-1402-2013— Elekta, Inc.

Name: FDA recall Z-1402-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-30

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-04-30, terminated 2017-07-26. It names one FDA 510(k) clearance: K121328. Product: Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.. Reason: Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-30
Terminated: 2017-07-26
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K121328 — AGILITYElekta , Ltd.·cleared 2012-06-12

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

Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

Reason for recall

Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.

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