Recall Z-0604-2016— Elekta, Inc.

Name: FDA recall Z-0604-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2015-12-18, terminated 2021-09-15. It names one FDA 510(k) clearance: K121448. Product: Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.. Reason: When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Terminated: 2021-09-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K121448 — ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHYElekta Inc. D/B/A Nucletron Corporation·cleared 2012-07-02

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

Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

Reason for recall

When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.

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